510(k) K102199 ยท LXB Hearing Aid, Bone Conduction
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
| Applicant | Sophono, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, May 23, 2011 |
| Received | Aug 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102199
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.