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

    CKIS-004A INJECTOR SYNCHRONIZATION OPTION

    K Number: K061976 · Decision Sep 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    146
    Review Days
    76

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    Basic Information

    Device Name
    CKIS-004A INJECTOR SYNCHRONIZATION OPTION
    K Number
    K061976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    July 13, 2006
    Decision Date
    September 27, 2006
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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