510(k) K100649 ยท LXB Hearing Aid, Bone Conduction
SOUNDBITE HEARING SYSTEM BY SONITUS
| Applicant | Sonitus Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | Mar 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100649
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.