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

    QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES

    K Number: K970391 · Decision Mar 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    9
    Review Days
    31

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    Basic Information

    Device Name
    QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
    K Number
    K970391
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contour Medical Technology, Inc.
    Date Received
    February 3, 1997
    Decision Date
    March 6, 1997
    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 Contour Medical Technology, Inc.

    K Number Device Name
    K970125 NOAH MONITORING ELECTRODE SYSTEM
    K960329 DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
    K952805 TEMPERATURE PROBE-TP550
    K952807 TEMPERATURE PROBE-TP650
    K952801 TEMPERATURE PROBE-TP250
    K952800 TEMPERATURE PROBE-TP150
    K952803 TEMPERATURE PROBE-TP350
    K952804 TEMPERATURE PROBE-TP450