510(k) K052465 ยท MKJ Automated External Defibrillators (Non-Wearable)
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
| Applicant | Heartsine Technologies, Inc., Newtown PA, US |
| Decision | Substantially Equivalent, Dec 12, 2006 |
| Received | Sep 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052465
| 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 |
| Oct 27, 2012 | Heartsine Technologies, Limited HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Product Usage: Samaritan 300/300P PAD is indicated for Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.