510(k) K791165 ยท DXY Implantable Pacemaker Pulse-Generator
ARCOLITH 4000
| Applicant | Arco Medical Products Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 10, 1979 |
| Received | Jun 25, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791165
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.