510(k) K212136 ยท LXB Hearing Aid, Bone Conduction
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
| Applicant | Cochlear Americas, Lone Tree CO, US |
| Decision | Substantially Equivalent, Sep 29, 2021 |
| Received | Jul 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212136
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.