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

    MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159

    K Number: K001698 · Decision Jul 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
    K Number
    K001698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cogent Light Technologies, Inc.
    Date Received
    June 2, 2000
    Decision Date
    July 17, 2000
    Product Code
    FFS
    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
    FFS Image, Illumination, Fiberoptic, For Endoscope

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