510(k) K191921 ยท PFO Active Implantable Bone Conduction Hearing System
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
| Applicant | Cochlear Americas, Centennial CO, US |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Jul 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191921
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.