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510(k) Data Aggregation

    K Number
    K112621
    Device Name
    WIS1000
    Manufacturer
    FORESEESON CUSTOM DISPLAYS, INC.
    Date Cleared
    2012-05-30

    (265 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORESEESON CUSTOM DISPLAYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.
    Device Description
    The WIS1000 System is a wireless transmitter and receiver pair which allows delivery of High Definition (HD) video from a wide range of video sources common in a hospital environment to a secondary video display.
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