K781798 is an FDA 510(k) clearance for the 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 November 3, 1978, 11 days after receiving the submission on October 23, 1978.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K781798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1978 |
| Decision Date | November 03, 1978 |
| Days to Decision | 11 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 |