BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160022 · Supplement: S013 · Decision Aug 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    ZOLL X Series, Propaq MD, and X Series Advanced
    PMA Number
    P160022
    Supplement Number
    S013
    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
    August 25, 2020
    Date Received
    September 3, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a software update to Version 02.34 (including implementation of Real Bag-Valve Mask Help Ventilation Feedback (Real BVM Help), a traumatic brain injury dashboard (TBI Dashboard), and the ability to retry to 12-Lead electrocardiograph report transmission up to five times), the addition of the AccuVent Sensor System accessory, and the rebranding of the device from X Series to X Series Advanced.

    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)