510(k) K081606 ยท LXB Hearing Aid, Bone Conduction
BAHA INTENSO
| Applicant | Cochlear Americas, Englewood CO, US |
| Decision | Substantially Equivalent, Aug 28, 2008 |
| Received | Jun 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081606
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.