510(k) K200504 ยท PFO Active Implantable Bone Conduction Hearing System
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
| Applicant | Med-El Elektromedizinische Geraete GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Jul 29, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200504
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.