21:8.0.1.1.24.1 | SUBPART A
| Subpart A - General Provisions | |
21:8.0.1.1.24.1.1.1 | SECTION 874.1
| 874.1 Scope. | |
21:8.0.1.1.24.1.1.2 | SECTION 874.3
| 874.3 Effective dates of requirement for premarket approval. | |
21:8.0.1.1.24.1.1.3 | SECTION 874.9
| 874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). | |
21:8.0.1.1.24.2 | SUBPART B
| Subpart B - Diagnostic Devices | |
21:8.0.1.1.24.2.1.1 | SECTION 874.1050
| 874.1050 Audiometer. | |
21:8.0.1.1.24.2.1.2 | SECTION 874.1060
| 874.1060 Acoustic chamber for audiometric testing. | |
21:8.0.1.1.24.2.1.3 | SECTION 874.1070
| 874.1070 Short increment sensitivity index (SISI) adapter. | |
21:8.0.1.1.24.2.1.4 | SECTION 874.1080
| 874.1080 Audiometer calibration set. | |
21:8.0.1.1.24.2.1.5 | SECTION 874.1090
| 874.1090 Auditory impedance tester. | |
21:8.0.1.1.24.2.1.6 | SECTION 874.1100
| 874.1100 Earphone cushion for audiometric testing. | |
21:8.0.1.1.24.2.1.7 | SECTION 874.1120
| 874.1120 Electronic noise generator for audiometric testing. | |
21:8.0.1.1.24.2.1.8 | SECTION 874.1325
| 874.1325 Electroglottograph. | |
21:8.0.1.1.24.2.1.9 | SECTION 874.1500
| 874.1500 Gustometer. | |
21:8.0.1.1.24.2.1.10 | SECTION 874.1600
| 874.1600 Olfactory test device. | |
21:8.0.1.1.24.2.1.11 | SECTION 874.1800
| 874.1800 Air or water caloric stimulator. | |
21:8.0.1.1.24.2.1.12 | SECTION 874.1820
| 874.1820 Surgical nerve stimulator/locator. | |
21:8.0.1.1.24.2.1.13 | SECTION 874.1925
| 874.1925 Toynbee diagnostic tube. | |
21:8.0.1.1.24.3 | SUBPART C
| Subpart C [Reserved] | |
21:8.0.1.1.24.4 | SUBPART D
| Subpart D - Prosthetic Devices | |
21:8.0.1.1.24.4.1.1 | SECTION 874.3300
| 874.3300 Hearing Aid. | |
21:8.0.1.1.24.4.1.2 | SECTION 874.3305
| 874.3305 Wireless air-conduction hearing aid. | |
21:8.0.1.1.24.4.1.3 | SECTION 874.3310
| 874.3310 Hearing aid calibrator and analysis system. | |
21:8.0.1.1.24.4.1.4 | SECTION 874.3315
| 874.3315 Tympanic membrane contact hearing aid. | |
21:8.0.1.1.24.4.1.5 | SECTION 874.3320
| 874.3320 Group hearing aid or group auditory trainer. | |
21:8.0.1.1.24.4.1.6 | SECTION 874.3325
| 874.3325 Self-fitting air-conduction hearing aid. | |
21:8.0.1.1.24.4.1.7 | SECTION 874.3330
| 874.3330 Master hearing aid. | |
21:8.0.1.1.24.4.1.8 | SECTION 874.3340
| 874.3340 Active implantable bone conduction hearing system. | |
21:8.0.1.1.24.4.1.9 | SECTION 874.3375
| 874.3375 Battery-powered artificial larynx. | |
21:8.0.1.1.24.4.1.10 | SECTION 874.3400
| 874.3400 Tinnitus masker. | |
21:8.0.1.1.24.4.1.11 | SECTION 874.3430
| 874.3430 Middle ear mold. | |
21:8.0.1.1.24.4.1.12 | SECTION 874.3450
| 874.3450 Partial ossicular replacement prosthesis. | |
21:8.0.1.1.24.4.1.13 | SECTION 874.3495
| 874.3495 Total ossicular replacement prosthesis. | |
21:8.0.1.1.24.4.1.14 | SECTION 874.3540
| 874.3540 Prosthesis modification instrument for ossicular replacement surgery. | |
21:8.0.1.1.24.4.1.15 | SECTION 874.3620
| 874.3620 Ear, nose, and throat synthetic polymer material. | |
21:8.0.1.1.24.4.1.16 | SECTION 874.3695
| 874.3695 Mandibular implant facial prosthesis. | |
21:8.0.1.1.24.4.1.17 | SECTION 874.3730
| 874.3730 Laryngeal prosthesis (Taub design). | |
21:8.0.1.1.24.4.1.18 | SECTION 874.3760
| 874.3760 Sacculotomy tack (Cody tack) | |
21:8.0.1.1.24.4.1.19 | SECTION 874.3820
| 874.3820 Endolymphatic shunt. | |
21:8.0.1.1.24.4.1.20 | SECTION 874.3850
| 874.3850 Endolymphatic shunt tube with valve. | |
21:8.0.1.1.24.4.1.21 | SECTION 874.3880
| 874.3880 Tympanostomy tube. | |
21:8.0.1.1.24.4.1.22 | SECTION 874.3900
| 874.3900 Nasal dilator. | |
21:8.0.1.1.24.4.1.23 | SECTION 874.3930
| 874.3930 Tympanostomy tube with semipermeable membrane. | |
21:8.0.1.1.24.4.1.24 | SECTION 874.3950
| 874.3950 Transcutaneous air conduction hearing aid system. | |
21:8.0.1.1.24.5 | SUBPART E
| Subpart E - Surgical Devices | |
21:8.0.1.1.24.5.1.1 | SECTION 874.4100
| 874.4100 Epistaxis balloon. | |
21:8.0.1.1.24.5.1.2 | SECTION 874.4140
| 874.4140 Ear, nose, and throat bur. | |
21:8.0.1.1.24.5.1.3 | SECTION 874.4175
| 874.4175 Nasopharyngeal catheter. | |
21:8.0.1.1.24.5.1.4 | SECTION 874.4180
| 874.4180 Eustachian tube balloon dilation system. | |
21:8.0.1.1.24.5.1.5 | SECTION 874.4250
| 874.4250 Ear, nose, and throat electric or pneumatic surgical drill. | |
21:8.0.1.1.24.5.1.6 | SECTION 874.4350
| 874.4350 Ear, nose, and throat fiberoptic light source and carrier. | |
21:8.0.1.1.24.5.1.7 | SECTION 874.4420
| 874.4420 Ear, nose, and throat manual surgical instrument. | |
21:8.0.1.1.24.5.1.8 | SECTION 874.4490
| 874.4490 Argon laser for otology, rhinology, and laryngology. | |
21:8.0.1.1.24.5.1.9 | SECTION 874.4500
| 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. | |
21:8.0.1.1.24.5.1.10 | SECTION 874.4680
| 874.4680 Bronchoscope (flexible or rigid) and accessories. | |
21:8.0.1.1.24.5.1.11 | SECTION 874.4710
| 874.4710 Esophagoscope (flexible or rigid) and accessories. | |
21:8.0.1.1.24.5.1.12 | SECTION 874.4720
| 874.4720 Mediastinoscope and accessories. | |
21:8.0.1.1.24.5.1.13 | SECTION 874.4750
| 874.4750 Laryngostroboscope. | |
21:8.0.1.1.24.5.1.14 | SECTION 874.4760
| 874.4760 Nasopharyngoscope (flexible or rigid) and accessories. | |
21:8.0.1.1.24.5.1.15 | SECTION 874.4770
| 874.4770 Otoscope. | |
21:8.0.1.1.24.5.1.16 | SECTION 874.4780
| 874.4780 Intranasal splint. | |
21:8.0.1.1.24.5.1.17 | SECTION 874.4800
| 874.4800 Bone particle collector. | |
21:8.0.1.1.24.6 | SUBPART F
| Subpart F - Therapeutic Devices | |
21:8.0.1.1.24.6.1.1 | SECTION 874.5220
| 874.5220 Ear, nose, and throat drug administration device. | |
21:8.0.1.1.24.6.1.2 | SECTION 874.5300
| 874.5300 Ear, nose, and throat examination and treatment unit. | |
21:8.0.1.1.24.6.1.3 | SECTION 874.5350
| 874.5350 Suction antichoke device. | |
21:8.0.1.1.24.6.1.4 | SECTION 874.5370
| 874.5370 Tongs antichoke device. | |
21:8.0.1.1.24.6.1.5 | SECTION 874.5550
| 874.5550 Powered nasal irrigator. | |
21:8.0.1.1.24.6.1.6 | SECTION 874.5800
| 874.5800 External nasal splint. | |
21:8.0.1.1.24.6.1.7 | SECTION 874.5840
| 874.5840 Antistammering device. | |
21:8.0.1.1.24.6.1.8 | SECTION 874.5900
| 874.5900 External upper esophageal sphincter compression device. | |