BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRUECPR COACHING DEVICE

    K Number: K123597 · Decision Apr 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    14
    Review Days
    147

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    Basic Information

    Device Name
    TRUECPR COACHING DEVICE
    K Number
    K123597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Physio-Control, Inc.
    Date Received
    November 21, 2012
    Decision Date
    April 17, 2013
    Product Code
    LIX
    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
    LIX Aid, Cardiopulmonary Resuscitation

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    K182503 Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
    K142430 LIFEPAK 15 monitor/defibrillator
    K130454 LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
    K122600 LIFEPAK 1000 DEFIBRILLATOR
    K103567 LIFEPAK 15 MONITOR/DEFIBRILLATOR
    K102972 LIFEPAK 12
    K102757 LIFENET SYSTEM
    K093925 LIFENET SYSTEM
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