510(k) K801978 ยท DXY Implantable Pacemaker Pulse-Generator
PROGRAMALITH #'S 221, 222, 221A & 222A
| Applicant | Pacesetter Systems, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 26, 1980 |
| Received | Aug 19, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801978
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.