510(k) K201983 ยท PFO Active Implantable Bone Conduction Hearing System
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
| Applicant | Med-El Elektromedizinische Geraete GmbH, Innsbruck, AT |
| Decision | Substantially Equivalent, Oct 9, 2020 |
| Received | Jul 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201983
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.