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

    XENON LIGHT SOURCE MODEL LS6000

    K Number: K981804 · Decision Jul 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    64

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    Basic Information

    Device Name
    XENON LIGHT SOURCE MODEL LS6000
    K Number
    K981804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical Vision, Ltd.
    Date Received
    May 21, 1998
    Decision Date
    July 24, 1998
    Product Code
    GCT
    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
    GCT Light Source, Endoscope, Xenon Arc

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    Other Clearances by Contec Medical Vision, Ltd.

    K Number Device Name
    K982962 XENON LIGHT SOURCE, MODELS LS6180, LS6035