21 CFR Part 874
PART 874—EAR, NOSE, AND THROAT DEVICES
- PART 874—EAR, NOSE, AND THROAT DEVICES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 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).
- Subpart B—Diagnostic Devices
- § 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.
- Subpart C [Reserved]
- Subpart D—Prosthetic Devices
- § 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.
- Subpart E—Surgical Devices
- § 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.
- Subpart F—Therapeutic Devices
- § 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.
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