510(k) K810142 ยท DXY Implantable Pacemaker Pulse-Generator
ELA MEDICAL UNILITH PULSE GENERATOR
| Applicant | Ela Medical, Inc. MD, US |
| Decision | Substantially Equivalent, May 29, 1981 |
| Received | Jan 21, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810142
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.