510(k) K003228 ยท MKJ Automated External Defibrillators (Non-Wearable)
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
| Applicant | Katecho, Inc., Des Moines IA, US |
| Decision | Substantially Equivalent, Dec 14, 2000 |
| Received | Oct 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2005 | Philips Medical Systems HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads
Model M3717A Terminated |
MLN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.