PMA P160032S014

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
Decision date: 2026-07-24
Classification: Cardiovascular
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.