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

    XENON LIGHT SOURCE MODEL 5121

    K Number: K952696 · Decision Jul 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    142
    Review Days
    42

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    Basic Information

    Device Name
    XENON LIGHT SOURCE MODEL 5121
    K Number
    K952696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    June 13, 1995
    Decision Date
    July 25, 1995
    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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