510(k) K952328 ยท DXY Implantable Pacemaker Pulse-Generator
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Sep 29, 1995 |
| Received | May 18, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952328
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.