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e-CFR data is current as of January 19, 2021

Title 21 → Chapter I → Subchapter H → Part 874

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 874—EAR, NOSE, AND THROAT DEVICES

rule

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).
rule

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.
rule

Subpart C—[RESERVED]

rule

Subpart D—PROSTHETIC DEVICES

§874.3300
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.
rule

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.
§874.4490
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.
rule

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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