BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FR MEDICAL X-RAY FILM

    K Number: K840806 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    60

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    Basic Information

    Device Name
    FR MEDICAL X-RAY FILM
    K Number
    K840806
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Fr Medical/Fr Chemicals
    Date Received
    February 24, 1984
    Decision Date
    April 24, 1984
    Product Code
    IWZ
    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
    IWZ Film, Radiographic

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