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

    THE CSE FILM CHANGER SYSTEM

    K Number: K854251 · Decision Oct 28, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    6

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    Basic Information

    Device Name
    THE CSE FILM CHANGER SYSTEM
    K Number
    K854251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1870
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Changer Service & Engineering, Inc.
    Date Received
    October 22, 1985
    Decision Date
    October 28, 1985
    Product Code
    IZP
    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
    IZP Programmer, Changer, Film/Cassette, Radiographic

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