BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RADIOGRAPHIC GRID

    K Number: K962338 · Decision Jul 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    RADIOGRAPHIC GRID
    K Number
    K962338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1910
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unidex Group, Inc.
    Date Received
    June 17, 1996
    Decision Date
    July 3, 1996
    Product Code
    IXJ
    Advisory Committee
    Radiology
    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
    IXJ Grid, Radiographic

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    Other Clearances by Unidex Group, Inc.

    K Number Device Name
    K962336 RADIOGRAPHIC FILM CASSETTES