510(k) K202048 ยท LXB Hearing Aid, Bone Conduction
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
| Applicant | Cochlear Americas, Lone Tree CO, US |
| Decision | Substantially Equivalent, Feb 23, 2021 |
| Received | Jul 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202048
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.