510(k) K153391 ยท LXB Hearing Aid, Bone Conduction
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
| Applicant | Sophono, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Nov 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153391
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.