510(k) K800379 ยท DXY Implantable Pacemaker Pulse-Generator
BIFOCAL 2 8200 SERIES (A,B C,D)
| Applicant | American Pacemaker Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 26, 1980 |
| Received | Feb 22, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800379
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.