510(k) K946188 ยท DXY Implantable Pacemaker Pulse-Generator
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
| Applicant | Cardiac Control Systems, Inc., Palm Coast FL, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., May 15, 1995 |
| Received | Dec 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946188
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.