BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160026 · Decision Jul 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
    PMA Number
    P160026
    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
    July 2, 2018
    Date Received
    July 25, 2016
    Expedited Review
    N
    Docket Number
    18M-2883

    Advisory Committee Statement

    Approval for the LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-ion Rechargeable Battery, LIFEPAK® 20 Defibrillator/ Monitor (Refurbished), LIFEPAK® 20e Defibrillator/ Monitor, LIFEPAK® 15 Monitor/Defibrillator, and LIFEPAK® Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Monitor/Defibrillator) These devices are indicated for use as follows:LIFEPAK® 1000 DefibrillatorThe defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.LIFEPAK® 20/20e Defibrillator/Monitors The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK® 20 and LIFEPAK® 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. LIFEPAK® 15 Defibrillator/Monitors AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ECG rhythm. In AED mode, the LIFEPAK® 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.

    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)