510(k) K180495 ยท KLW Masker, Tinnitus
Tinnitus Sound Generator Module
| Applicant | GN Hearing A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Nov 30, 2018 |
| Received | Feb 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180495
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.