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510(k) Data Aggregation

    K Number
    K082256
    Device Name
    LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
    Manufacturer
    INTEGRATED MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-09-26

    (49 days)

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

    INTEGRATED MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Life Support for Trauma and Transport (LSTAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The G6 Lite may be operated using either battery power or an external power source. The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
    Device Description
    The Integrated Medical Systems LSTAT G6 Lite is a portable intensive care unit (ICU) for adult and pediatric patients. The LSTAT G6 Lite combines the medical device capabilities of a physiological monitor, a ventilator, and infusion pumps into a single platform with a central display.
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