510(k) K221168 ยท KLW Masker, Tinnitus
Tinnitogram Signal Generator
| Applicant | Goldenear Company, Inc., Santa Clarita CA, US |
| Decision | Substantially Equivalent, Feb 1, 2023 |
| Received | Apr 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221168
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.