Part 874 Subpart B—Diagnostic Devices
FDA submissions for Part 874 Subpart B—Diagnostic Devices in the Ear, Nose, Throat (EN) review panel, including product codes and regulations.
Section range: §§ 874.1050–874.1925
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| EWO | Audiometer | 874.1050 | 2 | 235 |
| LYN | Apparatus, Visual Reinforcement Audiometric | 874.1050 | 2 | 3 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 874.1060 | 1 | 2 |
| ETR | Adaptor, Short Increment Sensitivity Index (Sisi) | 874.1070 | 1 | 0 |
| EWA | Set, Audiometer Calibration | 874.1080 | 1 | 2 |
| ETY | Tester, Auditory Impedance | 874.1090 | 2 | 70 |
| NAS | Tympanometer | 874.1090 | 2 | 2 |
| PTO | Tester, Auditory Impedance, Exempt | 874.1090 | 2 | 0 |
| PTP | Tympanometer, Exempt | 874.1090 | 2 | 0 |
| ETT | Cushion, Earphone (For Audiometric Testing) | 874.1100 | 1 | 0 |
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 874.1120 | 2 | 5 |
| KLX | Electroglottograph | 874.1325 | 2 | 4 |
| ETM | Gustometer, Sterile | 874.1500 | 1 | 0 |
| NNJ | Gustometer, Non-Sterile | 874.1500 | 1 | 0 |
| NRK | Kit, Test, Olfactory | 874.1600 | 2 | 1 |
| ETP | Stimulator, Caloric-Water | 874.1800 | 1 | 6 |
| KHH | Stimulator, Caloric-Air | 874.1800 | 1 | 7 |
| ETN | Stimulator, Nerve | 874.1820 | 2 | 97 |
| PDQ | Neurosurgical Nerve Locator | 874.1820 | 2 | 35 |
| QWP | Optical Neurosurgical Nerve Locator | 874.1820 | 2 | 1 |
| ETK | Tube, Toynbee Diagnostic | 874.1925 | 1 | 1 |
