K813557 is an FDA 510(k) clearance for the AUDITORY STIMULATOR. This device is classified as a Generator, Electronic Noise (for Audiometric Testing) (Class II - Special Controls, product code ETS).
Submitted by Western Advanced Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 19, 1982, 28 days after receiving the submission on December 22, 1981.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1120.
| 510(k) Number | K813557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1981 |
| Decision Date | January 19, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ETS — Generator, Electronic Noise (for Audiometric Testing) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1120 |