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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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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 - XXX |
| 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. |