510(k) K100193 ยท LXB Hearing Aid, Bone Conduction
OTOMAG BONE CONDUCTION HEARING SYSTEM
| Applicant | Sophono, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, May 18, 2010 |
| Received | Jan 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100193
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.