Generator, Electronic Noise (For Audiometric Testing)
FDA product code ETS · Class II (moderate risk) · 21 CFR 874.1120 · Ear, Nose, Throat
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K813557 | Auditory StimulatorETS · Traditional | Western Advanced Technology, Inc. | 01/19/1982SE |
| K811790 | Octotoxic ScreenerETS · Traditional | Western Advanced Technology, Inc. | 07/15/1981SE |
| K811772 | Auditory LocalizerETS · Traditional | Western Advanced Technology, Inc. | 07/15/1981SE |
| K790064 | Tinnitus DevicesETS · Traditional | Vicon Instrument Co. | 02/16/1979SE |
| K771188 | Reversing Click Generator RCG6ETS · Traditional | Teca, Inc. | 07/14/1977SE |