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

    CRONEX REGULAR CASSETTE

    K Number: K941475 · Decision Jul 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    28
    Review Days
    114

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    Basic Information

    Device Name
    CRONEX REGULAR CASSETTE
    K Number
    K941475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dupont Medical Products
    Date Received
    March 28, 1994
    Decision Date
    July 20, 1994
    Product Code
    IXA
    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
    IXA Cassette, Radiographic Film

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