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

    DAYLITE XENON LIGHT SOURCES

    K Number: K013880 · Decision Dec 7, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    DAYLITE XENON LIGHT SOURCES
    K Number
    K013880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Designs For Vision, Inc.
    Date Received
    November 23, 2001
    Decision Date
    December 7, 2001
    Product Code
    GCT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    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 Designs For Vision, Inc.

    K Number Device Name
    K051786 MELIDE FIBEROPTIC LIGHT
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    K801058 ILLUMINATED SPECULUM