510(k) K883037 ยท DXY Implantable Pacemaker Pulse-Generator
UNILITH 3 MODELS 7580/7583/7680/7683
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jan 25, 1989 |
| Received | Jul 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883037
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.