510(k) K203807 ยท MAH Hearing Aid, Bone Conduction, Implanted
Ponto Bone Anchored Hearing System, MONO Surgery Kit
| Applicant | Oticon Medical AB, Askim, SE |
| Decision | Substantially Equivalent, Mar 3, 2021 |
| Received | Dec 28, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203807
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.