BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P170018 · Decision Dec 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    LIFEPAK® CR2 Defibrillator
    PMA Number
    P170018
    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 21, 2018
    Date Received
    May 31, 2017
    Expedited Review
    N
    Docket Number
    19M-4916

    Advisory Committee Statement

    Approval for the LIFEPAK® CR2 Defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).The cprCOACH Feedback Technology in the LIFEPAK® CR2 Defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age and older.The LIFEPAK® CR2 Defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The LIFEPAK® CR2 Defibrillator is indicated to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery.

    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)