510(k) K882391 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Nov 14, 1988 |
| Received | Jun 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882391
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.