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510(k) Data Aggregation

    K Number
    K092219
    Device Name
    NAVIGATOR CLINICAL GUIDENCE SYSTEM
    Manufacturer
    APPLIED PHYSIOLOGY PTY LTD.
    Date Cleared
    2010-05-12

    (294 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED PHYSIOLOGY PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navigator™ is indicated for the acquisition, processing, and display of hemodynamic parameters, in order to assist the clinician in achieving and maintaining a prescribed target hemodynamic stability. Mean Systemic Filling Pressure (Pms) and Heart Efficiency (En) parameters are calculated by the Navigator from Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP) data, obtained directly from patient monitoring equipment, and other data obtained by manual clinician entry. The Navigator system provides a visual indication of the patient's circulatory status in relation to predetermined goals.
    Device Description
    The Navigator is a physiologically integrated system designed to assist clinicians in the management of the systemic circulatory state in the critically ill patient.
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