510(k) K955628 ยท MKJ Automated External Defibrillators (Non-Wearable)
FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
| Applicant | Heartstream, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Sep 10, 1996 |
| Received | Dec 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955628
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.