510(k) K841950 ยท DXY Implantable Pacemaker Pulse-Generator
PULSE GENERATOR KALOS-04
| Applicant | Biotronik Sales, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 25, 1984 |
| Received | May 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841950
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.