510(k) K923026 ยท DXY Implantable Pacemaker Pulse-Generator
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
| Applicant | Biotronik, GmbH & Co., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Aug 19, 1993 |
| Received | Jun 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923026
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.