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    K Number
    K151609
    Device Name
    ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
    Manufacturer
    NDS SURGICAL IMAGING LLC
    Date Cleared
    2015-11-06

    (144 days)

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

    NDS SURGICAL IMAGING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NDS ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.
    Device Description
    Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and EndoVue devices.
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