510(k) K011438 ยท LXB Hearing Aid, Bone Conduction
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
| Applicant | Entific Medical Systems, Inc., Findley MN, US |
| Decision | Substantially Equivalent, Jul 23, 2001 |
| Received | May 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011438
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.