EWA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Set, Audiometer Calibration
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.1080
- Medical specialty
- Ear, Nose, Throat
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OTOVIEW ENDOSCOPY SYSTEM (K934432) | Smith & Nephew Richards, Inc. | 1994-04-25 |
| AUDIOMETER CALIBRATOR MODEL RA 310 (K780474) | Tracor Instruments, Inc. | 1978-03-30 |
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Every clearance here is in the API, with alerts when new ones post.