510(k) K123962 ยท LXB Hearing Aid, Bone Conduction
OTOMAG BONE CONDUCTION HEARING SYSTEM
| Applicant | Sophono, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Apr 8, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123962
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.