510(k) K261142 ยท MAH Hearing Aid, Bone Conduction, Implanted
Ponto 5 Mini; Ponto 5 Superpower
| Applicant | Oticon Medical AB, Askim, SE |
| Decision | Substantially Equivalent, Aug 26, 2026 |
| Received | Apr 7, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261142
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.