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510(k) Data Aggregation

    K Number
    K973640
    Device Name
    TS2000 MEDICAL DEVICE MONITOR
    Date Cleared
    1998-03-12

    (169 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRINCORE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TS2000 Medical Device Monitor is intended to be used as a central monitoring station on those patients being monitored by pulse oximeter and infusion pump medical devices. It is used to provide a secondary display of the data from the medical devices to the centrally located TS2000 System display. It is intended for use by healthcare professionals trained in the use of the equipment only. The TS2000 is intended for use by healthcare professionals thoroughly familiar with the features and operations of the TS2000. The TS2000 is intended to supplement and not to replace any part of the current device monitoring procedures. The TS2000 is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care
    Device Description
    The TS2000 Medical Device Monitor is a PC based Central Monitoring Station that takes the information from different medical devices and redisplays them on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously at the central station. The TS2000 provides secondary annunciation of the alarms from the medical devices at the central station as well.
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