BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160032 · Decision Feb 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-
    PMA Number
    P160032
    Device Class
    FDA Class 3
    Product Code
    MKJ
    Generic Name
    Automated external defibrillators (non-wearable)
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 1, 2018
    Date Received
    August 2, 2016
    Expedited Review
    N
    Docket Number
    18M-0528

    Advisory Committee Statement

    Approval of the Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators.The Lifeline/ReviveR DDU-100 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-100 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-100). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-200P), if available.The Lifeline/ReviveR DDU-2000 series Automated External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and2) Not breathing or not breathing normally.Lifeline/ReviveR DDU-2000 series AEDs may be used with Defibtech adult defibrillation pads (model number DDP-2001). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use Defibtech child/infant defibrillation pads (model number DDP-2002), if available.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)