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

    KODAK MEDICAL X-RAY DEVELOPER & REPLEN.

    K Number: K801209 · Decision Jun 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    238
    Review Days
    37

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    Basic Information

    Device Name
    KODAK MEDICAL X-RAY DEVELOPER & REPLEN.
    K Number
    K801209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    May 20, 1980
    Decision Date
    June 26, 1980
    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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