510(k) K861009 ยท DXY Implantable Pacemaker Pulse-Generator
BIPOLAR CARDIAC PACEMAKER, MODEL 110
| Applicant | Cardiac Control Systems, Inc., Palm Coast FL, US |
| Decision | Substantially Equivalent, Apr 23, 1986 |
| Received | Mar 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861009
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.