510(k) K240614 ยท PFO Active Implantable Bone Conduction Hearing System
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
| Applicant | Oticon Medical AB, Askim, SE |
| Decision | Substantially Equivalent, Jul 10, 2024 |
| Received | Mar 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240614
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.