510(k) K771987 ยท DXY Implantable Pacemaker Pulse-Generator
MICROPULSE 26U PULSE GENERATOR
| Applicant | Edwards Pacemaker Systems, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 2, 1977 |
| Received | Oct 19, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771987
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.