BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160028 · Decision May 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    Philips HeartStart FR3 Defibrillator
    PMA Number
    P160028
    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 11, 2020
    Date Received
    July 29, 2016
    Expedited Review
    N
    Docket Number
    20M-1367

    Advisory Committee Statement

    Approval for the Philips HeartStart FR3 Defibrillator. The models 861388 and 861389 are indicated for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and pulseless ventricular tachycardias (VTs). The models 861388 and 861389 are used with the SmartPads III or DP defibrillator pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness;2) Absence of normal breathing; and3) Absence of pulse or signs of circulationThe models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or greater than 8 years old. The models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment.

    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)