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

    LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD

    K Number: K180583 · Decision Jun 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    11
    Review Days
    115

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    Basic Information

    Device Name
    LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
    K Number
    K180583
    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 Corporation
    Date Received
    March 5, 2018
    Decision Date
    June 28, 2018
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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