510(k) K830862 ยท DXY Implantable Pacemaker Pulse-Generator
NEDS-01 & EPR-500
| Applicant | Biotronik Sales, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 25, 1983 |
| Received | Mar 18, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830862
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.