510(k) K970072 ยท DXY Implantable Pacemaker Pulse-Generator
OPUS S MODEL 4121 AND 4124 PACEMAKERS
| Applicant | Ela Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 29, 1997 |
| Received | Jan 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970072
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.