510(k) K161671 ยท LXB Hearing Aid, Bone Conduction
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
| Applicant | Oticon Medical AB, Askim, SE |
| Decision | Substantially Equivalent, Sep 29, 2016 |
| Received | Jun 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161671
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.