K963995 is an FDA 510(k) clearance for the STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 26, 1996, 53 days after receiving the submission on October 4, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K963995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1996 |
| Decision Date | November 26, 1996 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KLW - Masker, Tinnitus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3400 |