510(k) K220922 ยท PFO Active Implantable Bone Conduction Hearing System
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
| Applicant | Cochlear Americas, Lone Tree CO, US |
| Decision | Substantially Equivalent, Jul 27, 2022 |
| Received | Mar 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220922
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.