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

    EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS

    K Number: K844774 · Decision Apr 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    2
    Applicant Total
    14
    Review Days
    133

    Basic Information

    Device Name
    EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
    K Number
    K844774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    MECRON MEDICAL PRODUCTS, INC.
    Date Received
    December 10, 1984
    Decision Date
    April 22, 1985
    Product Code
    FCR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCR Light Source, Photographic, Fiberoptic

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