510(k) K882476 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 12, 1988 |
| Received | Jun 15, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882476
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.