510(k) K260614 ยท KLW Masker, Tinnitus
Tinnitus Therapy
| Applicant | Sivantos GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Feb 25, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260614
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.