510(k) K915328 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
GEL-TAC
| Applicant | Katecho, Inc., Des Moines IA, US |
| Decision | Substantially Equivalent, Jun 29, 1992 |
| Received | Nov 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915328
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.