BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

    K Number: K951005 · Decision May 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
    K Number
    K951005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kenex , Ltd.
    Date Received
    February 15, 1995
    Decision Date
    May 4, 1995
    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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    Other Clearances by Kenex , Ltd.

    K Number Device Name
    K951004 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
    K951006 KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
    K951003 KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)