NAS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tympanometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1090
- Medical specialty
- Ear, Nose, Throat
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Otowave 302 Portable Tympanometer (K171265) | Amplivox, Ltd. | 2017-07-28 |
| Otowave 202 Portable Tympanometer (K150163) | Amplivox, Ltd. | 2015-04-23 |
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Every clearance here is in the API, with alerts when new ones post.