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

    MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    K Number: K012428 · Decision Sep 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
    K Number
    K012428
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Physio-Control Corp.
    Date Received
    July 31, 2001
    Decision Date
    September 28, 2001
    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 Medtronic Physio-Control Corp.

    K Number Device Name
    K040775 LIFEPAK 12
    K033275 LIFEPAK 12, 20, 500, CR PLUS
    K022732 INFANT/CHILD REDUCED ENERGY ELECTRODES
    K012274 MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
    K011144 LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
    K010918 LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
    K002445 LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES