510(k) K810901 ยท DXY Implantable Pacemaker Pulse-Generator
INSULATIVE COATING FOR CARD. PULSE GEN
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 14, 1981 |
| Received | Apr 3, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810901
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.