510(k) K770657 ยท DXY Implantable Pacemaker Pulse-Generator
GENERATOR, PULSE, CARDIAC 2LU
| Applicant | Edwards Pacemaker Systems, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 26, 1977 |
| Received | Apr 7, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K770657
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.