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510(k) Data Aggregation

    K Number
    K173036
    Device Name
    North-vision Multi-parameter Patient Monitor
    Date Cleared
    2018-12-21

    (449 days)

    Product Code
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    North-vision Tech. Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The North-vision Elegant-1000 Series of Multi-parameter Patient Monitor are intended to monitor, display and record physiological signs of adult, pediatric patients. With the functions of near real-time recording and displaying parameters ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, it allows comprehensive analysis of patient's physiological conditions. This apparatus is applicable for use in hospitals, clinics, and practitioner's office. The operation should be carried out by qualified professionals only.
    Device Description
    The Elegant-1000 Series are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. They are modular designed patient Monitors. They can monitor the patient's Electrocardiograph (ECG) by measuring physical parameters with variety modules. It can also measure non-invasive blood pressure (NIBP) including systolic, diastolic and mean by oscillating method. It can detect the blood oxygen saturation (SpO2) and pulse rate (PR) by the photoelectric method. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. After CPU analyzing and calculating the parameters are displayed on the screen in a graphical representation and it can record and/or print if necessary. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
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