BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    POWERHEART G5 AED

    K Number: K122758 · Decision Feb 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    520

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    Basic Information

    Device Name
    POWERHEART G5 AED
    K Number
    K122758
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiac Science Corporation
    Date Received
    September 10, 2012
    Decision Date
    February 12, 2014
    Product Code
    MKJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)

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    Other Clearances by Cardiac Science Corporation

    K Number Device Name
    K143714 Powerheart G5 AED
    K113176 MYSENSE HEART
    K102496 POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
    K093211 CARECENTER MD
    K091943 POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
    K082090 9131 DEFIBRILLATION ELECTRODES
    K082173 Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
    K060934 MODIFICATION TO POWERHEART ECD
    K060167 ATRIA 3100, ATRIA 6100