510(k) K972418 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)
| Applicant | Heartstream, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Sep 25, 1997 |
| Received | Jun 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972418
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.