510(k) K860922 ยท DXY Implantable Pacemaker Pulse-Generator
MIKROS, MIKROS VS-1, PULSE GENERATOR
| Applicant | Biotronik Sales, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Aug 4, 1986 |
| Received | Mar 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860922
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.