510(k) K905403 ยท DXY Implantable Pacemaker Pulse-Generator
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
| Applicant | Cook Pacemaker Corp., Leechburg PA, US |
| Decision | Substantially Equivalent, Oct 16, 1991 |
| Received | Dec 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905403
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.