510(k) K023854 ยท MKJ Automated External Defibrillators (Non-Wearable)
SAMARITAN AED, MODEL SAM-01
| Applicant | Heartsine Technologies, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Feb 14, 2003 |
| Received | Nov 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023854
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2005 | Heartsine Technologies Inc HeartSine Samaritan AED Defibrillators Models: SAM 001, SAM 002, SAM 003. Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.