510(k) K896184 ยท DXY Implantable Pacemaker Pulse-Generator
KALOS 05 PULSE GENERATOR
| Applicant | Biotronik Cardiac Pacemakers, Lake Oswego CA, US |
| Decision | Substantially Equivalent, Jan 18, 1990 |
| Received | Oct 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896184
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.