ETSClass II
Generator, Electronic Noise (For Audiometric Testing)
21 CFR 874.1120 / Ear, Nose, Throat
ETS is the FDA product code for Generator, Electronic Noise (For Audiometric Testing), a class II device type, regulated under 21 CFR 874.1120. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- ETS
- Device name
- Generator, Electronic Noise (For Audiometric Testing)
- Regulation
- 21 CFR 874.1120
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code ETS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1981 | 2 |
| 1982 | 1 |
Applicants with the most clearances
Product code ETS| Applicant | Clearances |
|---|---|
| Western Advanced Technology, Inc. | 3 |
| Teca, Inc. | 1 |
| Vicon Instrument Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code ETS.
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