510(k) K041067 ยท MKJ Automated External Defibrillators (Non-Wearable)
HEARTSINE SAMARITAN PAD
| Applicant | Heartsine Technologies, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, May 25, 2004 |
| Received | Apr 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.