510(k) K131240 ยท LXB Hearing Aid, Bone Conduction
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
| Applicant | Cochlear Americas, Centennial CO, US |
| Decision | Substantially Equivalent, Nov 7, 2013 |
| Received | May 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2014 | Cochlear Americas Inc. Cochlear Baha Soft tissue gauge 6mm.
Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. Terminated |
LXB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.