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

    ELITE R/F SPOT FILM DRIVE

    K Number: K902403 · Decision Aug 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    10
    Review Days
    62

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    Basic Information

    Device Name
    ELITE R/F SPOT FILM DRIVE
    K Number
    K902403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1670
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Rms Div.
    Date Received
    May 31, 1990
    Decision Date
    August 1, 1990
    Product Code
    IXL
    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
    IXL Device, Spot-Film

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