510(k) K830390 ยท DXY Implantable Pacemaker Pulse-Generator
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
| Applicant | Telectronics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Mar 24, 1983 |
| Received | Feb 10, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830390
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.