510(k) K033896 ยท MKJ Automated External Defibrillators (Non-Wearable)
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
| Applicant | Defibtech, LLC, Guilford CT, US |
| Decision | Substantially Equivalent, Jun 16, 2004 |
| Received | Dec 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2011 | Defibtech, LLC Defibtech Lifeline AED and ReviveR AED,
Model: DDU-100 Series AEDs
Software version 2.004 or earlier
The product under correction is the DDU-100 AED. The AED is indicated for use on victims of su Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.