510(k) K813246 ยท DXY Implantable Pacemaker Pulse-Generator
MEDICAL MULTILITH PULSE GENERA-1140
| Applicant | Ela Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 12, 1982 |
| Received | Nov 18, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813246
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.