510(k) K844841 ยท DXY Implantable Pacemaker Pulse-Generator
KALOS-04 PULSE GENERATOR
| Applicant | Biotronik Sales, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Apr 18, 1985 |
| Received | Dec 12, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844841
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.