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510(k) Data Aggregation

    K Number
    K101123
    Device Name
    NEXFIN MODEL 2
    Manufacturer
    BMEYE B.V.
    Date Cleared
    2010-10-28

    (189 days)

    Product Code
    DXN, DQA, DSB
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMEYE B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfin is indicated for use during both no motion and motion conditions and for patients who are well or poorly perfused. The CC Nexfin monitor does not feature (physiological) alarms, therefore the continuous availability of pulse-oximetry data should be treated as a series of spot-checks rather than continuous monitoring. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
    Device Description
    The BMEYE CC Nexfin hemodynamic monitor is a non-invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peňáz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters. The operation of the blood pressure and cardiac output measurement is identical to the operation in Nexfin Model 1 (K072049). The CC Nexfin enables in addition the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in combination with Masimo oximetry sensors. (K090238)
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    K Number
    K072049
    Device Name
    CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS
    Manufacturer
    BMEYE B.V.
    Date Cleared
    2007-11-29

    (127 days)

    Product Code
    DXN, DSB
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMEYE B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BMEYE NEXFIN_HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
    Device Description
    The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that enables the continuous assessment of a patient's cardiovascular function based on the scientific method of Peňáz - Wesseling. The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters.
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