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510(k) Data Aggregation

    K Number
    K980688
    Device Name
    INTEGRITI PATIENT MONITOR
    Manufacturer
    ALLIANCE INSTRUMENTS
    Date Cleared
    1999-03-16

    (386 days)

    Product Code
    MWI
    Regulation Number
    870.2300
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    Applicant Name (Manufacturer) :

    ALLIANCE INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.
    Device Description
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