510(k) K800194 ยท DXY Implantable Pacemaker Pulse-Generator
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
| Applicant | Coratomic, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 11, 1980 |
| Received | Jan 29, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800194
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.