510(k) K851081 ยท DXY Implantable Pacemaker Pulse-Generator
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
| Applicant | Telectronics, Inc., Suffield CT, US |
| Decision | Substantially Equivalent, Apr 4, 1985 |
| Received | Mar 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851081
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.