ETS — Generator, Electronic Noise (For Audiometric Testing) Class II
FDA product code ETS covers "Generator, Electronic Noise (For Audiometric Testing)", a Class II medical device regulated under 21 CFR 874.1120. Submissions are reviewed by the Ear, Nose, Throat panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ETS
- Device Class
- Class II
- Regulation Number
- 874.1120
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K813557 | western advanced technology | AUDITORY STIMULATOR | January 19, 1982 |
| K811772 | western advanced technology | AUDITORY LOCALIZER | July 15, 1981 |
| K811790 | western advanced technology | OCTOTOXIC SCREENER | July 15, 1981 |
| K790064 | vicon instrument | TINNITUS DEVICES | February 16, 1979 |
| K771188 | teca | REVERSING CLICK GENERATOR RCG6 | July 14, 1977 |