510(k) K780113 ยท DXY Implantable Pacemaker Pulse-Generator
CARDIAC PULSE GENERATOR, MODEL 160B
| Applicant | Telectronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 13, 1978 |
| Received | Jan 19, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780113
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.