K791790 is an FDA 510(k) clearance for the MODEL TM5 BEHIND EAR TINNITUS MASKER. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Starkey Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979, 45 days after receiving the submission on September 11, 1979.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K791790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1979 |
| Decision Date | October 26, 1979 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | KLW - Masker, Tinnitus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3400 |