TITLE 21--FOOD AND DRUGS 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.
§ 874.3430 - 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.
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