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Part 874
FEDERAL · 21 CFR
Part 874 — Ear, Nose, and Throat Devices
70 sections · Title 21: Food and Drugs
§ 874.1
Scope.
§ 874.3
Effective dates of requirement for premarket approval.
§ 874.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 874.1050
Audiometer.
§ 874.1060
Acoustic chamber for audiometric testing.
§ 874.1070
Short increment sensitivity index (SISI) adapter.
§ 874.1080
Audiometer calibration set.
§ 874.1090
Auditory impedance tester.
§ 874.1100
Earphone cushion for audiometric testing.
§ 874.1120
Electronic noise generator for audiometric testing.
§ 874.1325
Electroglottograph.
§ 874.1500
Gustometer.
§ 874.1600
Olfactory test device.
§ 874.1800
Air or water caloric stimulator.
§ 874.1820
Surgical nerve stimulator/locator.
§ 874.1925
Toynbee diagnostic tube.
§ 874.3300
Air-conduction hearing aid.
§ 874.3302
Bone-conduction hearing aid.
§ 874.3305
Wireless air-conduction hearing aid.
§ 874.3310
Hearing aid calibrator and analysis system.
§ 874.3315
Tympanic membrane contact hearing aid.
§ 874.3320
Group hearing aid or group auditory trainer.
§ 874.3325
Self-fitting air-conduction hearing aid.
§ 874.3330
Master hearing aid.
§ 874.3340
Active implantable bone conduction hearing system.
§ 874.3375
Battery-powered artificial larynx.
§ 874.3400
Tinnitus masker.
§ 874.3410
Combined acoustic and electrical external stimulation device for the relief of tinnitus.
§ 874.3430
Middle ear mold.
§ 874.3450
Partial ossicular replacement prosthesis.
§ 874.3495
Total ossicular replacement prosthesis.
§ 874.3540
Prosthesis modification instrument for ossicular replacement surgery.
§ 874.3620
Ear, nose, and throat synthetic polymer material.
§ 874.3695
Mandibular implant facial prosthesis.
§ 874.3730
Laryngeal prosthesis (Taub design).
§ 874.3760
Sacculotomy tack (Cody tack)
§ 874.3820
Endolymphatic shunt.
§ 874.3850
Endolymphatic shunt tube with valve.
§ 874.3880
Tympanostomy tube.
§ 874.3900
Nasal dilator.
§ 874.3930
Tympanostomy tube with semipermeable membrane.
§ 874.3950
Transcutaneous air conduction hearing aid system.
§ 874.4100
Epistaxis balloon.
§ 874.4140
Ear, nose, and throat bur.
§ 874.4175
Nasopharyngeal catheter.
§ 874.4180
Eustachian tube balloon dilation system.
§ 874.4250
Ear, nose, and throat electric or pneumatic surgical drill.
§ 874.4350
Ear, nose, and throat fiberoptic light source and carrier.
§ 874.4420
Ear, nose, and throat manual surgical instrument.
§ 874.4450
Powered insertion system for a cochlear implant electrode array.
§ 874.4490
Argon laser for otology, rhinology, and laryngology.
§ 874.4500
Ear, nose, and throat microsurgical carbon dioxide laser.
§ 874.4680
Bronchoscope (flexible or rigid) and accessories.
§ 874.4710
Esophagoscope (flexible or rigid) and accessories.
§ 874.4720
Mediastinoscope and accessories.
§ 874.4750
Laryngostroboscope.
§ 874.4760
Nasopharyngoscope (flexible or rigid) and accessories.
§ 874.4770
Otoscope.
§ 874.4780
Intranasal splint.
§ 874.4800
Bone particle collector.
§ 874.5220
Ear, nose, and throat drug administration device.
§ 874.5300
Ear, nose, and throat examination and treatment unit.
§ 874.5350
Suction antichoke device.
§ 874.5370
Tongs antichoke device.
§ 874.5550
Powered nasal irrigator.
§ 874.5800
External nasal splint.
§ 874.5840
Antistammering device.
§ 874.5900
External upper esophageal sphincter compression device.
§ 874.5950
Oropharyngeal electrical stimulator.
§ 874.6000
Transcutaneous electrical nerve stimulator for the relief of congestion.