510(k) K980857 ยท MKJ Automated External Defibrillators (Non-Wearable)
MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE
| Applicant | Graphic Controls Corp., Buffalo NY, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Mar 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980857
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.