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

    MXR-14 FILM PROCESSOR

    K Number: K890486 · Decision Apr 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    1
    Review Days
    427

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    Basic Information

    Device Name
    MXR-14 FILM PROCESSOR
    K Number
    K890486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Cordell, Inc.
    Date Received
    January 31, 1989
    Decision Date
    April 3, 1990
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

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