510(k) K191457 ยท PFO Active Implantable Bone Conduction Hearing System
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
| Applicant | Med-El Elektromedizinische Geraete GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | May 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191457
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.