510(k) K231204 · PFO Active Implantable Bone Conduction Hearing System
Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App
| Applicant | Cochlear, Lone Tree CO, US |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Apr 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231204
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.