K221168 is an FDA 510(k) clearance for the Tinnitogram Signal Generator. This device is classified as a Masker, Tinnitus (Class II - Special Controls, product code KLW).
Submitted by Goldenear Company, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on February 1, 2023, 285 days after receiving the submission on April 22, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3400.
| 510(k) Number | K221168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2022 |
| Decision Date | February 01, 2023 |
| Days to Decision | 285 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 |