ETS
5 FDA 510(k) clearances · Product code
23 daysmedian time to decision
32 days90th percentile
5clearances measured
FDA profile
- Official device name
- Generator, Electronic Noise (For Audiometric Testing)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1120
- Medical specialty
- Ear, Nose, Throat
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AUDITORY STIMULATOR (K813557) | Western Advanced Technology, Inc. | 1982-01-19 |
| OCTOTOXIC SCREENER (K811790) | Western Advanced Technology, Inc. | 1981-07-15 |
| AUDITORY LOCALIZER (K811772) | Western Advanced Technology, Inc. | 1981-07-15 |
| TINNITUS DEVICES (K790064) | Vicon Instrument Co. | 1979-02-16 |
| REVERSING CLICK GENERATOR RCG6 (K771188) | Teca, Inc. | 1977-07-14 |
Track ETS automatically
Every clearance here is in the API, with alerts when new ones post.