BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160034 · Decision Dec 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Powerheart® AED G3 Pro
    PMA Number
    P160034
    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 6, 2018
    Date Received
    August 4, 2016
    Expedited Review
    N
    Docket Number
    18M-4672

    Advisory Committee Statement

    Approval for the Powerheart® AED G3 Pro.The Powerheart® AED G3 Pro is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are:1) unresponsive;2) not breathing normally; and3) without pulse.When the patient is a child or infant up to 8 years of age, or up to 55 lbs. (25kg), the device should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.The Powerheart® AED G3 Pro is intended to be used by personnel who have been trained in its operation.

    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)