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

    PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

    K Number: K983314 · Decision Feb 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    151

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    Basic Information

    Device Name
    PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
    K Number
    K983314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nycomed Amersham Imaging
    Date Received
    September 21, 1998
    Decision Date
    February 19, 1999
    Product Code
    IZQ
    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
    IZQ Injector, Contrast Medium, Automatic

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