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

    VS-100 ILLUMINATION AND IMAGING SYSTEM

    K Number: K090800 · Decision May 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    VS-100 ILLUMINATION AND IMAGING SYSTEM
    K Number
    K090800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Schoelly Imaging, Inc.
    Date Received
    March 24, 2009
    Decision Date
    May 18, 2009
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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