BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P180028 · 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
    HeartStart FRx Defibrillator
    PMA Number
    P180028
    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
    August 3, 2018
    Expedited Review
    N
    Docket Number
    20M-1368

    Advisory Committee Statement

    Approval for the HeartStart FRx Defibrillator (Model 861304). The device is indicated for use on potential victims of sudden cardiac arrest (SCA) with the following symptoms:1) Unconsciousness; and2) Absence of normal breathingThe HeartStart FRx (Model 861304) is indicated for adults over 55 pounds (25 kg). The Model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key (Model 989803139311). If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, proceed using adult treatment without the infant/child key.

    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)