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

    AECD ARRHYTHMIA DETECTION SOFTWARE

    K Number: K982710 · Decision Aug 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    10
    Review Days
    6

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    Basic Information

    Device Name
    AECD ARRHYTHMIA DETECTION SOFTWARE
    K Number
    K982710
    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
    August 4, 1998
    Decision Date
    August 10, 1998
    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
    K993533 POWERHEART AECD
    K970741 POWERHEART AECD