美国FDA医疗器械分类目录查询 -耳、鼻、喉

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FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 874

EAR, NOSE, AND THROAT 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 - 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.
   § 874.4490 - 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.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

Extracted from US.FDA

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