BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160015 · Decision May 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    AED Plus and Fully Automatic AED Plus
    PMA Number
    P160015
    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
    May 26, 2017
    Date Received
    June 2, 2016
    Expedited Review
    N
    Docket Number
    17M-3372

    Advisory Committee Statement

    Approval for the AED Plus and Fully Automatic AED Plus. These devices are indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of normal breathing; and3) Absence of a pulse or signs of circulationThese devices are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the ZOLL AED Plus® and Fully Automatic AED Plus® should be used with the ZOLL AED Plus and Fully Automatic AED Plus® Pediatric Electrodes. Therapy should not be delayed to determine the patients exact age or weight.

    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)