510(k) K121228 ยท MAH Hearing Aid, Bone Conduction, Implanted
PONTO BONE ANCHORED HEARING SYSTEM
| Applicant | Oticon Medical AB, Askim, SE |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Apr 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121228
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.