510(k) K952364 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Sep 1, 1995 |
| Received | May 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952364
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.