PMA P160032

Device
Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S010
Product code
MKJ
Decision date
2026-07-24
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
extending the Defibtech DDU-2000 series AED to the new VIEW 2 series which include models: Lifeline VIEW 2 model DDU-2950, Lifeline VIEW 2 AUTO DDU-2955, Lifeline ECG 2 DDU-2960, and the Universal Pads accessory model DDP-2004.

Current openFDA PMA Record#

Device
Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
Applicant
Defibtech, LLC
PMA number
P160032
Supplement
S014
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2026-07-24
Decision code
APPR
Date received
2025-07-09
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
extending the Defibtech DDU-2000 series AED to the new VIEW 2 series which include models: Lifeline VIEW 2 model DDU-2950, Lifeline VIEW 2 AUTO DDU-2955, Lifeline ECG 2 DDU-2960, and the Universal Pads accessory model DDP-2004.