BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    POWERHEART AECD

    K Number: K993533 · Decision Jan 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    97

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    Basic Information

    Device Name
    POWERHEART AECD
    K Number
    K993533
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Cardiac Science, Inc.
    Date Received
    October 19, 1999
    Decision Date
    January 24, 2000
    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
    K052316 POWERHEART ECD
    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
    K982710 AECD ARRHYTHMIA DETECTION SOFTWARE
    K970741 POWERHEART AECD