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

    INTELLIVUE CLINICAL INFORMATION PORTFOLIO

    K Number: K100272 · Decision Apr 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    107
    Review Days
    75

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    Basic Information

    Device Name
    INTELLIVUE CLINICAL INFORMATION PORTFOLIO
    K Number
    K100272
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    January 29, 2010
    Decision Date
    April 14, 2010
    Product Code
    DXJ
    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
    DXJ Display, Cathode-Ray Tube, Medical

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