510(k) K882474 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
| 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 K882474
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.