BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160022 · Decision Dec 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
    PMA Number
    P160022
    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 27, 2017
    Date Received
    July 7, 2016
    Expedited Review
    N
    Docket Number
    17M-7004

    Advisory Committee Statement

    Approval for the X Series Defibrillator Function. The X Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulseThe X Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The X Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The X Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. R Series Defibrillator FunctionThe R Series system is indicated for defibrillation on victims of cardiac arrest where there is apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse.The R Series system in the Manual mode is indicated for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.The R Series system Semiautomatic and Manual mode is indicated for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.The R Series system Semiautomatic and Manual mode is indicated for adult and pediatric patients. AED ProThe AED Pro system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The device is also indicated for use when ECG monitoring is indicated to evaluate the patient’s heart rate or ECG morphology. The AED Pro system is indicated for adult and pediatric patients.AED 3 BLSThe ZOLL AED 3 system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by:1) Unconsciousness;2) Absence of breathing; and3) Absence of pulse and other signs of circulation.The AED 3 system is indicated for adult and pediatric patients. ...

    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)