510(k) K240155 ยท PFO Active Implantable Bone Conduction Hearing System
Cochlear Osia System
| Applicant | Cochlear Americas, Lone Tree CO, US |
| Decision | Substantially Equivalent, Apr 18, 2024 |
| Received | Jan 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240155
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.