510(k) K993434 ยท DXY Implantable Pacemaker Pulse-Generator
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Nov 10, 1999 |
| Received | Oct 12, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993434
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.