510(k) K854195 ยท DXY Implantable Pacemaker Pulse-Generator
PROGRAMALITH III MODELS 238 & 239
| Applicant | Pacesetter Systems, Sylmar CA, US |
| Decision | Substantially Equivalent, Jan 7, 1986 |
| Received | Oct 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854195
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.