510(k) K221125 ยท KLW Masker, Tinnitus
SilentCloud
| Applicant | Aureliym GmbH, Bad Neuenahr-Ahrweiler, DE |
| Decision | Substantially Equivalent, Jan 4, 2023 |
| Received | Apr 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221125
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.