510(k) K894185 ยท DXY Implantable Pacemaker Pulse-Generator
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
| Applicant | Telectronics Pacing Systems, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Aug 17, 1989 |
| Received | Jun 16, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894185
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.