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

    CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM

    K Number: K062265 · Decision Dec 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    144

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    Basic Information

    Device Name
    CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
    K Number
    K062265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Swiss Medical Care S.A.
    Date Received
    August 4, 2006
    Decision Date
    December 26, 2006
    Product Code
    IZQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZQ Injector, Contrast Medium, Automatic

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