BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160022 · Supplement: S016 · Decision Dec 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera
    PMA Number
    P160022
    Supplement Number
    S016
    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
    December 19, 2022
    Date Received
    January 31, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following ZOLL automated external defibrillator (AED) accessories: ZOLL® Pedi-padz® Liquid Gel Electrodes, ZOLL® Adult Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Liquid Gel Electrodes, ZOLL® Pro-padz® Radiolucent Electrodes, ZOLL® Pedi-padz® Radiolucent Electrodes, ZOLL® CPR-D-padz® Electrodes, ZOLL® CPR Stat-padz® Electrodes, ZOLL® CPR Dura-padz® Reusable Electrodes.

    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)