Appendix B to Subpart B of Part 26—Scope of Product Coverage

Appendix B - Appendix B to Subpart B of Part 26—Scope of Product Coverage

1. Initial Coverage of the Transition Period Upon entry into force of this subpart as described in § 26.80 (it is understood that the date of entry into force will not occur prior to June 1, 1998, unless the parties decide otherwise), products qualifying for the transitional arrangements under this subpart include: a. All Class I products requiring premarket evaluations in the United States—see Table 1. b. Those Class II products listed in Table 2. 2. During the Transition Period The parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows: a. Those for which review may be based primarily on written guidance which the parties will use their best efforts to prepare expeditiously; and b. Those for which review may be based primarily on international standards, in order for the parties to gain the requisite experience. The corresponding additional product lists will be phased in on an annual basis. The parties may consult with industry and other interested parties in determining which products will be added. 3. Commencement of the Operational Period a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period. b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with FDA's ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States. 4. Unless explicitly included by joint decision of the parties, this part does not cover any U.S. Class II-tier 3 or any Class III product under either system.

[The lists of medical devices included in these tables are subject to change as a result of the Food and Drug Administration Modernization Act of 1997.]

Table 1—Class I Products Requiring Premarket Evaluations in the United States, Included in Scope of Product Coverage at Beginning of Transition Period 1

21 CFR Section No.	Regulation Name		Product Code—Device Name	Anesthesiology Panel (21 CFR part 868)		868.1910	Esophageal Stethoscope		BZW—Stethoscope, Esophageal	868.5620	Breathing Mouthpiece		BYP—Mouthpiece, Breathing	868.5640	Medicinal Nonventilatory Nebulizer (Atomizer)		CCQ—Nebulizer, Medicinal, Nonventilatory (Atomizer)	868.5675	Rebreathing Device		BYW—Device, Rebreathing	868.5700	Nonpowered Oxygen Tent		FOG—Hood, Oxygen, Infant		BYL—Tent, Oxygen	868.6810	Tracheobronchial Suction Catheter		BSY—Catheters, Suction, Tracheobronchial	Cardiovascular Panel		(None)		Dental Panel (21 CFR part 872)		872.3400	Karaya and Sodium Borate With or Without Acacia Denture Adhesive		KOM—Adhesive, Denture, Acacia and Karaya With Sodium Borate	872.3700	Dental Mercury (U.S.P.)		ELY—Mercury	872.4200	Dental Handpiece and Accessories		EBW—Controller, Food, Handpiece and Cord		EFB—Handpiece, Air-Powered, Dental		EFA—Handpiece, Belt and/or Gear Driven, Dental		EGS—Handpiece, Contra- and Right-Angle Attachment, Dental		EKX—Handpiece, Direct Drive, AC-Powered		EKY—Handpiece, Water-Powered	872.6640	Dental Operative Unit and Accessories		EIA—Unit, Operative Dental	Ear, Nose, and Throat Panel (21 CFR Part 874)		874.1070	Short Increment Sensitivity Index (SISI) Adapter		Espan—Adapter, Short Increment Sensitivity Index (SISI)	874.1500	Gustometer		ETM—Gustometer	874.1800	Air or Water Caloric Stimulator		KHH—Stimulator, Caloric-Air		ETP—Stimulator, Caloric-Water	874.1925	Toynbee Diagnostic Tube		ETK—Tube, Toynbee Diagnostic	874.3300	Hearing Aid		LRB—Face Plate Hearing-Aid		ESD—Hearing-aid, Air-Conduction	874.4100	Epistaxis Balloon		EMX—Balloon, Epistaxis	874.5300	ENT Examination and Treatment Unit		ETF—Unit, Examining/Treatment, ENT	874.5550	Powered Nasal Irrigator		KMA—Irrigator, Powered Nasal	874.5840	Antistammering Device		KTH—Device, Anti-Stammering	Gastroenterology—Urology Panel (21 CFR Part 876)		876.5160	Urological Clamp for Males		FHA—Clamp, Penile	876.5210	Enema Kit		FCE—Kit, Enema, (for Cleaning Purpose)	876.5250	Urine Collector and Accessories		FAQ—Bag, Urine Collection, Leg, for External Use	General Hospital Panel (21 CFR Part 880)		880.5270	Neonatal Eye Pad		FOK—Pad, Neonatal Eye	880.5420	Pressure Infusor for an I.V. Bag		KZD—Infusor, Pressure, for I.V. Bags	880.5680	Pediatric Position Holder		FRP—Holder, Infant Position	880.6250	Patient Examination Glove		LZB—Finger Cot		FMC—Glove, Patient Examination		LYY—Glove, Patient Examination, Latex		LZA—Glove, Patient Examination, Poly		LZC—Glove, Patient Examination, Speciality		LYZ—Glove, Patient Examination, Vinyl	880.6375	Patient Lubricant		KMJ—Lubricant, Patient	880.6760	Protective Restraint		BRT—Restraint, Patient, Conductive		FMQ—Restraint, Protective	Neurology Panel (21 CFR Part 882)		882.1030	Ataxiagraph		GWW—Ataxiagraph	882.1420	Electroencephalogram (EEG) Signal Spectrum Analyzer		GWS—Analyzer, Spectrum, Electroencephalogram Signal	882.4060	Ventricular Cannula		HCD—Cannula, Ventricular	882.4545	Shunt System Implantation Instrument		GYK—Instrument, Shunt System Implantation	882.4650	Neurosurgical Suture Needle		HAS—Needle, Neurosurgical Suture	882.4750	Skull Punch		GXJ—Punch, Skull	Obstetrics and Gynecology Panel		(None)		Ophthalmology Panel (21 CFR Part 886)		886.1780	Retinoscope		HKM—Retinoscope, Battery-Powered	886.1940	Tonometer Sterilizer		HKZ—Sterilizer, Tonometer	886.4070	Powered Corneal Burr		HQS—Burr, Corneal, AC-Powered		HOG—Burr, Corneal, Battery-Powered		HRG—Engine, Trephine, Accessories, AC-Powered		HFR—Engine, Trephine, Accessories, Battery-Powered		HLD—Engine, Trephine, Accessories, Gas-Powered	886.4370	Keratome		HNO—Keratome, AC-Powered		HMY—Keratome, Battery-Powered	886.5850	Sunglasses (Nonprescription)		HQY—Sunglasses (Nonprescription Including Photosensitive)	Orthopedic Panel (21 CFR Part 888)		888.1500	Goniometer		KQX—Goniometer, AC-Powered	888.4150	Calipers for Clinical Use		KTZ—Caliper	Physical Medicine Panel (21 CFR Part 890)		890.3850	Mechanical Wheelchair		LBE—Stroller, Adaptive		IOR—Wheelchair, Mechanical	890.5180	Manual Patient Rotation Bed		INY—Bed, Patient Rotation, Manual	890.5710	Hot or Cold Disposable Pack		IMD—Pack, Hot or Cold, Disposable	Radiology Panel (21 CFR Part 892)		892.1100	Scintillation (Gamma) Camera		IYX—Camera, Scintillation (Gamma)	892.1110	Positron Camera		IZC—Camera, Positron	892.1300	Nuclear Rectilinear Scanner		IYW—Scanner, Rectilinear, Nuclear	892.1320	Nuclear Uptake Probe		IZD—Probe, Uptake, Nuclear	892.1330	Nuclear Whole Body Scanner		JAM—Scanner, Whole Body, Nuclear	892.1410	Nuclear Electrocardiograph Synchronizer		IVY—Synchronizer, Electrocardiograph, Nuclear	892.1890	Radiographic Film Illuminator		IXC—Illuminator, Radiographic-Film		JAG—Illuminator, Radiographic-Film, Explosion-Proof	892.1910	Radiographic Grid		IXJ—Grid, Radiographic	892.1960	Radiographic Intensifying Screen		EAM—Screen, Intensifying, Radiographic	892.1970	Radiographic ECG/Respirator Synchronizer		IXO—Synchronizer, ECG/Respirator, Radiographic	892.5650	Manual Radionuclide Applicator System		IWG—System, Applicator, Radionuclide, Manual	General and Plastic Surgery Panel (21 CFR Part 878)		878.4200	Introduction/Drainage Catheter and Accessories		KGZ—Accessories, Catheter		GCE—Adaptor, Catheter		FGY—Cannula, Injection		GBA—Catheter, Balloon Type		GBZ—Catheter, Cholangiography		GBQ—Catheter, Continuous Irrigation		GBY—Catheter, Eustachian, General & Plastic Surgery		JCY—Catheter, Infusion		GBX—Catheter, Irrigation		GBP—Catheter, Multiple Lumen		GBO—Catheter, Nephrostomy, General & Plastic Surgery		GBN—Catheter, Pediatric, General & Plastic Surgery		GBW—Catheter, Peritoneal		GBS—Catheter, Ventricular, General & Plastic Surgery		GCD—Connector, Catheter		GCC—Dilator, Catheter		GCB—Needle, Catheter	878.4320	Removable Skin Clip		FZQ—Clip, Removable (Skin)	878.4460	Surgeon's Gloves		KGO—Surgeon's Gloves	878.4680	Nonpowered, Single Patient, Portable Suction Apparatus		GCY—Apparatus, Suction, Single Patient Use, Portable, Nonpowered	878.4760	Removable Skin Staple		GDT—Staple, Removable (Skin)	878.4820	AC-Powered, Battery-Powered, and Pneumatically Powered Surgical Instrument Motors and Accessories/Attachments		GFG—Bit, Surgical		GFA—Blade, Saw, General & Plastic Surgery		DWH—Blade, Saw, Surgical, Cardiovascular		BRZ—Board, Arm (With Cover)		GFE—Brush, Dermabrasion		GFF—Bur, Surgical, General & Plastic Surgery		KDG—Chisel (Osteotome)		GFD—Dermatome		GFC—Driver, Surgical, Pin		GFB—Head, Surgical, Hammer		GEY—Motor, Surgical Instrument, AC-Powered		GET—Motor, Surgical Instrument, Pneumatic Powered		DWI—Saw, Electrically Powered		KFK—Saw, Pneumatically Powered		HAB—Saw, Powered, and Accessories	878.4960	Air or AC-Powered Operating Table and Air or AC-Powered Operating Chair & Accessories		GBB—Chair, Surgical, AC-Powered		FQO—Table, Operating-Room, AC-Powered		GDC—Table, Operating-Room, Electrical		FWW—Table, Operating-Room, Pneumatic		JEA—Table, Surgical with Orthopedic Accessories, AC-Powered	880.5090	Liquid Bandage		KMF—Bandage, Liquid

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

Table 2—Class II Medical Devices Included in Scope of Product Coverage at Beginning of Transition Period (United States to develop guidance documents identifying U.S. requirements and European Community (EC) to identify standards needed to meet EC requirements) 1

Panel	21 CFR Section No.	Regulation Name			Product Code—Device Name	RA	892.1000	Magnetic Resonance Diagnostic Device			MOS—COIL, Magnetic Resonance, Specialty			LNH—System, Nuclear Magnetic Resonance Imaging			LNI—System, Nuclear Magnetic Resonance Spectroscopic	Diagnostic Ultrasound:			RA	892.1540	Nonfetal Ultrasonic Monitor			JAF—Monitor, Ultrasonic, Nonfetal	RA	892.1550	Ultrasonic Pulsed Doppler Imaging System			IYN—System, Imaging, Pulsed Doppler, Ultrasonic	RA	892.1560	Ultrasonic Pulsed Echo Imaging System			IYO—System, Imaging, Pulsed Echo, Ultrasonic	RA	892.1570	Diagnostic Ultrasonic Transducer			ITX—Transducer, Ultrasonic, Diagnostic	Diagnostic X-Ray Imaging Devices (except mammographic x-ray systems):			RA	892.1600	Angiographic X-Ray System			IZI—System, X-Ray, Angiographic	RA	892.1650	Image-Intensified Fluoroscopic X-Ray System			MQB—Solid State X-Ray Imager (Flat Panel/Digital Imager)			JAA—System, X-Ray, Fluoroscopic, Image-Intensified	RA	892.1680	Stationary X-Ray System			KPR—System, X-Ray, Stationary	RA	892.1720	Mobile X-Ray System			IZL—System, X-Ray, Mobile	RA	892.1740	Tomographic X-Ray System			IZF—System, X-Ray, Tomographic	RA	892.1750	Computed Tomography X-Ray System			JAK—System, X-Ray, Tomography, Computed	ECG-Related Devices:			CV	870.2340	Electrocardiograph			DPS—Electrocardiograph			MLC—Monitor, ST Segment	CV	870.2350	Electrocardiograph Lead Switching Adaptor			DRW—Adaptor, Lead Switching, Electrocardiograph	CV	870.2360	Electrocardiograph Electrode			DRX—Electrode, Electrocardiograph	CV	870.2370	Electrocardiograph Surface Electrode Tester			KRC—Tester, Electrode, Surface, Electrocardiographic	NE	882.1400	Electroencephalograph			GWQ—Electroencephalograph	HO	880.5725	Infusion Pump (external only)			MRZ—Accessories, Pump, Infusion			FRN—Pump, Infusion			LZF—Pump, Infusion, Analytical Sampling			MEB—Pump, Infusion, Elastomeric			LZH—Pump, Infusion, Enteral			MHD—Pump, Infusion, Gallstone Dissolution			LZG—Pump, Infusion, Insulin			MEA—Pump, Infusion, PCA	Ophthalmic Instruments:			OP	886.1570	Ophthalmoscope			HLI—Ophthalmoscope, AC-Powered			HLJ—Ophthalmoscope, Battery-Powered	OP	886.1780	Retinoscope			HKL—Retinoscope, AC-Powered	OP	886.1850	AC-Powered Slit-Lamp Biomicroscope			HJO—Biomicroscope, Slit-Lamp, AC-Powered	OP	886.4150	Vitreous Aspiration and Cutting Instrument			MMC—Dilator, Expansive Iris (Accessory)			HQE—Instrument, Vitreous Aspiration and Cutting, AC-Powered			HKP—Instrument, Vitreous Aspiration and Cutting, Battery-Powered			MLZ—Vitrectomy, Instrument Cutter	OP	886.4670	Phacofragmentation System			HQC—Unit, Phacofragmentation	SU	878.4580	Surgical Lamp			HBI—Illuminator, Fiberoptic, Surgical Field			FTF—Illuminator, Nonremote			FTG—Illuminator, Remote			HJE—Lamp, Fluorescein, AC-Powered			FQP—Lamp, Operating-Room			FTD—Lamp, Surgical			GBC—Lamp, Surgical, Incandescent			FTA—Light, Surgical, Accessories			FSZ—Light, Surgical, Carrier			FSY—Light, Surgical, Ceiling Mounted			FSX—Light, Surgical, Connector			FSW—Light, Surgical, Endoscopic			FST—Light, Surgical, Fiberoptic			FSS—Light, Surgical, Floor Standing			FSQ—Light, Surgical, Instrument	NE	882.5890	Transcutaneous Electrical Nerve Stimulator for Pain Relief			GZJ—Stimulator, Nerve, Transcutaneous, For Pain Relief			Noninvasive Blood Pressure Measurement Devices:	CV	870.1120	Blood Pressure Cuff			DXQ—Cuff, Blood-Pressure	CV	870.1130	Noninvasive Blood Pressure Measurement System (except nonoscillometric)			DXN—System, Measurement, Blood-Pressure, Noninvasive	HO	880.6880	Steam Sterilizer (greater than 2 cubic feet)			FLE—Sterilizer, Steam	Clinical Thermometers:			HO	880.2910	Clinical Electronic Thermometer (except tympanic or pacifier)			FLL—Thermometer, Electronic, Clinical	AN	868.5630	Nebulizer			CAF—Nebulizer (Direct Patient Interface)	Hypodermic Needles and Syringes (except antistick and self-destruct):			HO	880.5570	Hypodermic Single Lumen Needle			MMK—Container, Sharpes			FMI—Needle, Hypodermic, Single Lumen			MHC—Port, Intraosseous, Implanted	HO	880.5860	Piston Syringe			FMF—Syringe, Piston	Selected Dental Materials:			DE	872.3060	Gold-Based Alloys and Precious Metal Alloys for Clinical Use			EJT—Alloy, Gold Based, For Clinical Use			EJS—Alloy, Precious Metal, For Clinical Use	DE	872.3200	Resin Tooth Bonding Agent			KLE—Agent, Tooth Bonding, Resin	DE	872.3275	Dental Cement			EMA—Cement, Dental			EMB—Zinc Oxide Eugenol	DE	872.3660	Impression Material			ELW—Material, Impression	DE	872.3690	Tooth Shade Resin Material			EBF—Material, Tooth Shade, Resin	DE	872.3710	Base Metal Alloy			EJH—Metal, Base	Latex Condoms:			OB	884.5300	Condom			HIS—Condom

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

Table 3—Medical Devices for Possible Inclusion in Scope of Product Coverage During Operational Period 1

Product Family	21 CFR Section No	Device Name	Tier	Anesthesiology Panel				Anesthesia Devices	868.5160	Gas machine for anesthesia or analgesia	2		868.5270	Breathing system heater	2		868.5440	Portable oxygen generator	2		868.5450	Respiratory gas humidifier	2		868.5630	Nebulizer	2		868.5710	Electrically powered oxygen tent	2		868.5880	Anesthetic vaporizer	2	Gas Analyser	868.1040	Powered Algesimeter	2		868.1075	Argon gas analyzer	2		868.1400	Carbon dioxide gas analyzer	2		868.1430	Carbon monoxide gas analyzer	2		868.1500	Enflurane gas analyzer	2		868.1620	Halothane gas analyzer	2		868.1640	Helium gas analyzer	2		868.1670	Neon gas analyzer	2		868.1690	Nitrogen gas analyzer	2		868.1700	Nitrous oxide gas analyzer	2		868.1720	Oxygen gas analyzer	2		868.1730	Oxygen uptake computer	2	Peripheral Nerve Stimulators	868.2775	Electrical peripheral nerve stimulator	2	Respiratory Monitoring	868.1750	Pressure plethysmograph	2		868.1760	Volume plethysmograph	2		868.1780	Inspiratory airway pressure meter	2		868.1800	Rhinoanemometer	2		868.1840	Diagnostic spirometer	2		868.1850	Monitoring spirometer	2		868.1860	Peak-flow meter for spirometry	2		868.1880	Pulmonary-function data calculator	2		868.1890	Predictive pulmonary-function value calculator	2		868.1900	Diagnostic pulmonary-function interpretation calculator	2		868.2025	Ultrasonic air embolism monitor	2		868.2375	Breathing frequency monitor (except apnea detectors)	2		868.2480	Cutaneous carbon dioxide (PcCO2) monitor	2		868.2500	Cutaneous oxygen monitor (for an infant not under gas anesthesia)	2		868.2550	Pneumotachomometer	2		868.2600	Airway pressure monitor	2		868.5665	Powered percussor	2		868.5690	Incentive spirometer	2	Ventilator	868.5905	Noncontinuous ventilator (IPPB)	2		868.5925	Powered emergency ventilator	2		868.5935	External negative pressure ventilator	2		868.5895	Continuous ventilator	2		868.5955	Intermittent mandatory ventilation attachment	2		868.6250	Portable air compressor	2	Cardiovascular Panel				Cardiovascular Diagnostic	870.1425	Programmable diagnostic computer	2		870.1450	Densitometer	2		870.2310	Apex cardiograph (vibrocardiograph)	2		870.2320	Ballistocardiograph	2		870.2340	Electrocardiograph	2		870.2350	Electrocardiograph lead switching adaptor	1		870.2360	Electrocardiograph electrode	2		870.2370	Electrocardiograph surface electrode tester	2		870.2400	Vectorcardiograph	1		870.2450	Medical cathode-ray tube display	1		870.2675	Oscillometer	2		870.2840	Apex cardiographic transducer	2		870.2860	Heart sound transducer	2	Cardiovascular Monitoring		Valve, pressure relief, cardiopulmonary bypass			870.1100	Blood pressure alarm	2		870.1110	Blood pressure computer	2		870.1120	Blood pressure cuff	2		870.1130	Noninvasive blood pressure measurement system	2		870.1140	Venous blood pressure manometer	2		870.1220	Electrode recording catheter or electrode recording probe	2		870.1270	Intracavitary phonocatheter system	2		870.1875	Stethoscope (electronic)	2		870.2050	Biopotential amplifier and signal conditioner	2		870.2060	Transducer signal amplifier and conditioner	2		870.2100	Cardiovascular blood flow-meter	2		870.2120	Extravascular blood flow probe	2		870.2300	Cardiac monitor (including cardiotachometer and rate alarm)	2		870.2700	Oximeter	2		870.2710	Ear oximeter	2		870.2750	Impedance phlebograph	2		870.2770	Impedance plethysmograph	2		870.2780	Hydraulic, pneumatic, or photoelectric plethysmographs	2		870.2850	Extravascular blood pressure transducer	2		870.2870	Catheter tip pressure transducer	2		870.2880	Ultrasonic transducer	2		870.2890	Vessel occlusion transducer	2		870.2900	Patient transducer and electrode cable (including connector)	2		870.2910	Radiofrequency physiological signal transmitter and receiver	2		870.2920	Telephone electrocardiograph transmitter and receiver	2		870.4205	Cardiopulmonary bypass bubble detector	2		870.4220	Cardiopulmonary bypass heart-lung machine console	2		870.4240	Cardiovascular bypass heat exchanger	2		870.4250	Cardiopulmonary bypass temperature controller	2		870.4300	Cardiopulmonary bypass gas control unit	2		870.4310	Cardiopulmonary bypass coronary pressure gauge	2		870.4330	Cardiopulmonary bypass on-line blood gas monitor	2		870.4340	Cardiopulmonary bypass level sensing monitor and/or control	2		870.4370	Roller-type cardiopulmonary bypass blood pump	2		870.4380	Cardiopulmonary bypass pump speed control	2		870.4410	Cardiopulmonary bypass in-line blood gas sensor	2	Cardiovascular Therapeutic	870.5050	Patient care suction apparatus	2		870.5900	Thermal regulation system	2	Defibrillator	870.5300	DC-defibrillator (including paddles)	2		870.5325	Defibrillator tester	2	Echocardiograph	870.2330	Echocardiograph	2	Pacemaker & Accessories	870.1750	External programmable pacemaker pulse generator	2		870.3630	Pacemaker generator function analyzer	2		870.3640	Indirect pacemaker generator function analyzer	2		870.3720	Pacemaker electrode function tester	2	Miscellaneous	870.1800	Withdrawal-infusion pump	2		870.2800	Medical magnetic tape recorder	2		None	Batteries, rechargeable, class II devices		Dental Panel				Dental Equipment	872.1720	Pulp tester	2		872.1740	Caries detection device	2		872.4120	Bone cutting instrument and accessories	2		872.4465	Gas-powered jet injector	2		872.4475	Spring-powered jet injector	2		872.4600	Intraoral ligature and wire lock	2		872.4840	Rotary scaler	2		872.4850	Ultrasonic scaler	2		872.4920	Dental electrosurgical unit and accessories	2		872.6070	Ultraviolet activator for polymerization	2		872.6350	Ultraviolet detector	2	Dental Material	872.3050	Amalgam alloy	2		872.3060	Gold-based alloys and precious metal alloys for clinical use	2		872.3200	Resin tooth bonding agent	2		872.3250	Calcium hydroxide cavity liner	2		872.3260	Cavity varnish	2		872.3275	Dental cement (other than zinc oxide-eugenol)	2		872.3300	Hydrophilic resin coating for dentures	2		872.3310	Coating material for resin fillings	2		872.3590	Preformed plastic denture tooth	2		872.3660	Impression material	2		872.3690	Tooth shade resin material	2		872.3710	Base metal alloy	2		872.3750	Bracket adhesive resin and tooth conditioner	2		872.3760	Denture relining, repairing, or rebasing resin	2		872.3765	Pit and fissure sealant and conditioner	2		872.3770	Temporary crown and bridge resin	2		872.3820	Root canal filling resin (other than chloroform use)	2		872.3920	Porcelain tooth	2	Dental X-ray	872.1800	Extraoral source x-ray system	2		872.1810	Intraoral source x-ray system	2	Dental Implants	872.4880	Intraosseous fixation screw or wire	2		872.3890	Endodontic stabilizing splint	2	Orthodontic	872.5470	Orthodontic plastic bracket	2	Ear/Nose/Throat Panel				Diagnostic Equipment	874.1050	Audiometer	2		874.1090	Auditory impedance tester	2		874.1120	Electronic noise generator for audiometric testing	2		874.1325	Electroglottograph	2		874.1820	Surgical nerve stimulator/locator	2	Hearing Aids	874.3300	Hearing aid (for bone-conduction)	2		874.3310	Hearing aid calibrator and analysis system	2		874.3320	Group hearing aid or group auditory trainer	2		874.3330	Master hearing aid	2	Surgical Equipment	874.4250	Ear, nose, and throat electric or pneumatic surgical drill	1		874.4490	Argon laser for otology, rhinology, and laryngology	2		874.4500	Ear, nose, and throat microsurgical carbon dioxide laser	2	Gastroenterology/Urology Panel				Endoscope (including angioscopes, laparscopes, ophthalmic endoscopes)	876.1500	Endoscope and accessories	2		876.4300	Endoscopic electrosurgical unit and accessories	2	Gastroenterology	876.1725	Gastrointestinal motility monitoring system	1	Hemodialysis	876.5600	Sorbent regenerated dialysate delivery system for hemodialysis	2		876.5630	Peritoneal dialysis system and accessories	2		876.5665	Water purification system for hemodialysis	2		876.5820	Hemodialysis system and accessories	2		876.5830	Hemodialyzer with disposable insert (kiil-type)	2	Lithotriptor	876.4500	Mechanical lithotriptor	2	Urology Equipment	876.1620	Urodynamics measurement system	2		876.5320	Nonimplanted electrical continence device	2		876.5880	Isolated kidney perfusion and transport system and accessories	2	General Hospital Panel				Infusion Pumps and Systems	880.2420	Electronic monitor for gravity flow infusion systems	2		880.2460	Electrically powered spinal fluid pressure monitor	2		880.5430	Nonelectrically powered fluid injector	2		880.5725	Infusion pump	2	Neonatal Incubators	880.5400	Neonatal incubator	2		880.5410	Neonatal transport incubator	2		880.5700	Neonatal phototherapy unit	2	Piston Syringes	880.5570	Hypodermic single lumen needle	1		880.5860	Piston syringe (except antistick)	1		880.6920	Syringe needle introducer	2	Miscellaneous	880.2910	Clinical electronic thermometer	2		880.2920	Clinical mercury thermometer	2		880.5100	AC-powered adjustable hospital bed	1		880.5500	AC-powered patient lift	2		880.6880	Steam sterilizer (greater than 2 cubic feet)	2	Neurology Panel					882.1020	Rigidity analyzer	2		882.1610	Alpha monitor	2	Neuro-Diagnostic	882.1320	Cutaneous electrode	2		882.1340	Nasopharyngeal electrode	2		882.1350	Needle electrode	2		882.1400	Electroencephalograph	2		882.1460	Nystagmograph	2		882.1480	Neurological endoscope	2		882.1540	Galvanic skin response measurement device	2		882.1550	Nerve conduction velocity measurement device	2		882.1560	Skin potential measurement device	2		882.1570	Powered direct-contact temperature measurement device	2		882.1620	Intracranial pressure monitoring device	2		882.1835	Physiological signal amplifier	2		882.1845	Physiological signal conditioner	2		882.1855	Electroencephalogram (EEG) telemetry system	2		882.5050	Biofeedback device	2	Echoencephalography	882.1240	Echoencephalograph	2	RPG	882.4400	Radiofrequency lesion generator	2	Neuro Surgery	none	Electrode, spinal epidural	2		882.4305	Powered compound cranial drills, burrs, trephines, and their accessories	2		882.4310	Powered simple cranial drills burrs, trephines, and their accessories	2		882.4360	Electric cranial drill motor	2		882.4370	Pneumatic cranial drill motor	2		882.4560	Stereotaxic instrument	2		882.4725	Radiofrequency lesion probe	2		882.4845	Powered rongeur	2		882.5500	Lesion temperature monitor	2	Stimulators	882.1870	Evoked response electrical stimulator	2		882.1880	Evoked response mechanical stimulator	2		882.1890	Evoked response photic stimulator	2		882.1900	Evoked response auditory stimulator	2		882.1950	Tremor transducer	2		882.5890	Transcutaneous electrical nerve stimulator for pain relief	2	Obstetrics/Gynecology Panel				Fetal Monitoring	884.1660	Transcervical endoscope (amnioscope) and accessories	2		884.1690	Hysteroscope and accessories (for performance standards)	2		884.2225	Obstetric-gynecologic ultrasonic imager	2		884.2600	Fetal cardiac monitor	2		884.2640	Fetal phonocardiographic monitor and accessories	2		884.2660	Fetal ultrasonic monitor and accessories	2		884.2675	Fetal scalp circular (spiral) electrode and applicator	1		884.2700	Intrauterine pressure monitor and accessories	2		884.2720	External uterine contraction monitor and accessories	2		884.2740	Perinatal monitoring system and accessories	2		884.2960	Obstetric ultrasonic transducer and accessories	2	Gynecological Surgery Equipment	884.1720	Gynecologic laparoscope and accessories	2		884.4160	Unipolar endoscopic coagulator-cutter and accessories	2		884.4550	Gynecologic surgical laser	2		884.4120	Gynecologic electrocautery and accessories	2		884.5300	Condom	2	Ophthalmic Implants	886.3320	Eye sphere implant	2	Contact Lens	886.1385	Polymethylmethacrylate (PMMA) diagnostic contact lens	2		886.5916	Rigid gas permeable contact lens (daily wear only)	2	Diagnostic Equipment	886.1120	Opthalmic camera	1		886.1220	Corneal electrode	1		886.1250	Euthyscope (AC-powered)	1		886.1360	Visual field laser instrument	1		886.1510	Eye movement monitor	1		886.1570	Ophthalmoscope	1		886.1630	AC-powered photostimulator	1		886.1640	Ophthalmic preamplifier	1		886.1670	Ophthalmic isotope uptake probe	2		886.1780	Retinoscope (AC-powered device)	1		886.1850	AC-powered slit lamp biomicroscope	1		886.1930	Tonometer and accessories	2		886.1945	Transilluminator (AC-powered device)	1		886.3130	Ophthalmic conformer	2	(Diagnostic/Surgery Equipment)	886.4670	Phacofragmentation system	2	Ophthalmic Implants	886.3340	Extraocular orbital implant	2		886.3800	Scleral shell	2	Surgical Equipment	880.5725	Infusion pump (performance standards)	2		886.3100	Ophthalmic tantalum clip	2		886.3300	Absorbable implant (scleral buckling method)	2		886.4100	Radiofrequency electrosurgical cautery apparatus	2		886.4115	Thermal cautery unit	2		886.4150	Vitreous aspiration and cutting instrument	2		886.4170	Cryophthalmic unit	2		886.4250	Ophthalmic electrolysis unit (AC-powered device)	1		886.4335	Operating headlamp (AC-powered device)	1		886.4390	Ophthalmic laser	2		886.4392	Nd:YAG laser for posterior capsulotomy	2		886.4400	Electronic metal locator	1		886.4440	AC-powered magnet	1		886.4610	Ocular pressure applicator	2		886.4690	Ophthalmic photocoagulator	2		886.4790	Ophthalmic sponge	2		886.5100	Ophthalmic beta radiation source	2		none	Ophthalmoscopes, replacement batteries, hand-held	1	Orthopedic Panel				Implants	888.3010	Bone fixation cerclage	2		888.3020	Intramedullary fixation rod	2		888.3030	Single/multiple component metallic bone fixation appliances and accessories	2		888.3040	Smooth or threaded metallic bone fixation fastener	2		888.3050	Spinal interlaminal fixation orthosis	2		888.3060	Spinal intervertebral body fixation orthosis	2	Surgical Equipment	888.1240	AC-powered dynamometer	2		888.4580	Sonic surgical instrument and accessories/attachments	2		none	Accessories, fixation, spinal interlaminal	2		none	Accessories, fixation, spinal intervertebral body	2		none	Monitor, pressure, intracompartmental	1		none	Orthosis, fixation, spinal intervertebral fusion	2		none	Orthosis, spinal pedicle fixation			none	System, cement removal extraction	1	Physical Medicine Panel				Diagnostic Equipment or (Therapy) Therapeutic Equipment	890.1225	Chronaximeter	2		890.1375	Diagnostic electromyograph	2		890.1385	Diagnostic electromyograph needle electrode	2		890.1450	Powered reflex hammer	2		890.1850	Diagnostic muscle stimulator	2	or (Therapy)	890.5850	Powered muscle stimulator	2	Therapeutic Equipment	890.5100	Immersion hydrobath	2		890.5110	Paraffin bath	2		890.5500	Infrared lamp	2		890.5720	Water circulating hot or cold pack	2		890.5740	Powered heating pad	2	Radiology Panel				MRI	892.1000	Magnetic resonance diagnostic device	2	Ultrasound Diagnostic	884.2660	Fetal ultrasonic monitor and accessories	2		892.1540	Nonfetal ultrasonic monitor			892.1560	Ultrasonic pulsed echo imaging system	2		892.1570	Diagnostic ultrasonic transducer	2		892.1550	Ultrasonic pulsed doppler imaging system		Angiographic	892.1600	Angiographic x-ray system	2	Diagnostic X-Ray	892.1610	Diagnostic x-ray beam-limiting device	2		892.1620	Cine or spot fluorographic x-ray camera	2		892.1630	Electrostatic x-ray imaging system	2		892.1650	Image-intensified fluoroscopic x-ray system	2		892.1670	Spot film device	2		892.1680	Stationary x-ray system	2		892.1710	Mammographic x-ray system	2		892.1720	Mobile x-ray system	2		892.1740	Tomographic x-ray system	1		892.1820	Pneumoencephalographic chair	2		892.1850	Radiographic film cassette	1		892.1860	Radiographic film/cassette changer	1		892.1870	Radiographic film/cassette changer programmer	2		892.1900	Automatic radiographic film processor	2		892.1980	Radiologic table	1	CT Scanner	892.1750	Computed tomography x-ray system	2	Radiation Therapy	892.5050	Medical charged-particle radiation therapy system	2		892.5300	Medical neutron radiation therapy system	2		892.5700	Remote controlled radionuclide applicator system	2		892.5710	Radiation therapy beam-shaping block	2		892.5730	Radionuclide brachytherapy source	2		892.5750	Radionuclide radiation therapy system	2		892.5770	Powered radiation therapy patient support assembly	2		892.5840	Radiation therapy simulation system	2		892.5930	Therapeutic x-ray tube housing assembly	1	Nuclear Medicine	892.1170	Bone densitometer	2		892.1200	Emission computed tomography system	2		892.1310	Nuclear tomography system	1		892.1390	Radionuclide rebreathing system	2	General/Plastic Surgery Panel				Surgical Lamps	878.4630	Ultraviolet lamp for dermatologic disorders	2		890.5500	Infrared lamp	2		878.4580	Surgical lamp	2	Electrosurgical Cutting Equipment	878.4810	Laser surgical instrument for use in general and plastic surgery and in dermatology	2		878.4400	Electrosurgical cutting and coagulation device and accessories	2	Miscellaneous	878.4780	Powered suction pump	2

1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA's Internet Web Site at http://www.fda.gov/cdrh/prodcode.html.

[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]