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510(k) Data Aggregation

    K Number
    K231116
    Device Name
    Multi-parameter detector
    Manufacturer
    Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
    Date Cleared
    2024-06-15

    (422 days)

    Product Code
    MNW, DQA, DXN, FLL
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults. The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
    Device Description
    The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm. The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
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