510(k) K123881 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSINE SAMARITAN PAD 350P
| Applicant | Heartsine Technologies, Inc., Northern, IE |
| Decision | Substantially Equivalent, Jul 11, 2013 |
| Received | Dec 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2014 | Heartsine Technologies, Limited Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P).
Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically design Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.