Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122381

    Validate with FDA (Live)

    Device Name
    NEXFIN MODEL 2
    Date Cleared
    2013-04-22

    (259 days)

    Product Code
    Regulation Number
    870.1130
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 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 CC Nexfin also enables the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The operation of the blood pressure, cardiac output, SpO2 and SpHb measurement are identical to the operation in the predicate (K101123).

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1