510(k) K894065 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS MODEL 4001
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 26, 1989 |
| Received | Jun 8, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894065
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.