510(k) K830401 ยท DXY Implantable Pacemaker Pulse-Generator
UNILITH PULSE GENERATOR VVI #7542
| Applicant | Ela Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 17, 1983 |
| Received | Feb 7, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830401
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.