510(k) K852641 ยท DXY Implantable Pacemaker Pulse-Generator
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
| Applicant | Sorin Biomedica, Fiat, USA, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jan 14, 1986 |
| Received | Jun 20, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852641
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.