510(k) K900461 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 14, 1990 |
| Received | Jan 31, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900461
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.