510(k) K012404 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
| Applicant | Katecho, Inc., Des Moines IA, US |
| Decision | Substantially Equivalent, Oct 12, 2001 |
| Received | Jul 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012404
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.