510(k) K190589 ยท PFO Active Implantable Bone Conduction Hearing System
Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
| Applicant | Cochlear Americas, Centennial CO, US |
| Decision | Substantially Equivalent, Jul 3, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190589
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.