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

    FLUORICON 500 IMAGE INTENSIFIERS

    K Number: K770094 · Decision Jan 21, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    34
    Applicant Total
    254
    Review Days
    4

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    Basic Information

    Device Name
    FLUORICON 500 IMAGE INTENSIFIERS
    K Number
    K770094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    General Electric Co.
    Date Received
    January 17, 1977
    Decision Date
    January 21, 1977
    Product Code
    EAM
    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
    EAM Screen, Intensifying, Radiographic

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