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

    POWERHEART ECD

    K Number: K052316 · Decision Jan 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    131

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    Basic Information

    Device Name
    POWERHEART ECD
    K Number
    K052316
    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, Inc.
    Date Received
    August 25, 2005
    Decision Date
    January 3, 2006
    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, Inc.

    K Number Device Name
    K052161 POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
    K040637 POWERHEART AED G3 PRO
    K040438 POWERHEART AED G3A
    K022929 PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210
    K022210 MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
    K012197 POWERHEART CARDIAC RHYTHM MODULE
    K993533 POWERHEART AECD
    K982710 AECD ARRHYTHMIA DETECTION SOFTWARE
    K970741 POWERHEART AECD