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

    MCKESSON CARDIOLOGY HEMO

    K Number: K131497 · Decision Dec 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    5
    Review Days
    195

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    Basic Information

    Device Name
    MCKESSON CARDIOLOGY HEMO
    K Number
    K131497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mckesson Israel , Ltd.
    Date Received
    May 24, 2013
    Decision Date
    December 5, 2013
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Mckesson Israel , Ltd.

    K Number Device Name
    K151850 McKesson Cardiology
    K133534 MCKESSON CARDIOLOGY ECG MOBILE
    K113515 HORIZON CARDIOLOGY ECG MANAGEMENT
    K112720 MCKESSON HORIZON CARDIOLOGY