510(k) K914109 ยท DXY Implantable Pacemaker Pulse-Generator
PIKOS 01 & PIKOS E 01
| Applicant | Biotronik, GmbH & Co., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Feb 26, 1992 |
| Received | Sep 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914109
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.