BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216

    K Number: K111905 · Decision Oct 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    25
    Review Days
    91

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    Basic Information

    Device Name
    INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
    K Number
    K111905
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
    Date Received
    July 5, 2011
    Decision Date
    October 4, 2011
    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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