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

    XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

    K Number: K062895 · Decision Oct 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    4
    Review Days
    16

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    Basic Information

    Device Name
    XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
    K Number
    K062895
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic Research Center International BV
    Date Received
    September 27, 2006
    Decision Date
    October 13, 2006
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MPA Endoilluminator

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