510(k) K897116 ยท DXY Implantable Pacemaker Pulse-Generator
OPTIMA MPT MODEL 5281E AND MODEL 5282E
| Applicant | Telectronics Pacing Systems, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Mar 14, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897116
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.