510(k) K863898 ยท DXY Implantable Pacemaker Pulse-Generator
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
| Applicant | Ela Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Feb 10, 1987 |
| Received | Oct 7, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863898
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.