510(k) K812218 ยท DXY Implantable Pacemaker Pulse-Generator
KALOS-03
| Applicant | Biotronik Sales, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 13, 1981 |
| Received | Aug 6, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812218
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.