510(k) K183373 ยท PFO Active Implantable Bone Conduction Hearing System
Bonebridge
| Applicant | Med-El Elektromedizinische Geraete GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Mar 7, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183373
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.