510(k) K882427 ยท DXY Implantable Pacemaker Pulse-Generator
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 23, 1988 |
| Received | Jun 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882427
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.