510(k) K013896 ยท MKJ Automated External Defibrillators (Non-Wearable)
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
| Applicant | Defibtech, LLC, Guilford CT, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jun 19, 2002 |
| Received | Nov 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013896
| 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 |
| Oct 18, 2010 | Defibtech, LLC DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED).
The DDC-6-AA data card is an accessory to the AED and does not have its own intended use. Terminated |
MKJ | None listed |
| Jun 10, 2010 | Defibtech LLC Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AE Terminated |
MKJ | None listed |
| Jun 10, 2010 | Defibtech LLC ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AED and do Terminated |
MKJ | None listed |
| Mar 8, 2007 | Defibtech, LLC Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier) Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.