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510(k) Data Aggregation

    K Number
    K201384
    Device Name
    Pulse Oximeter
    Date Cleared
    2020-12-07

    (195 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Raysintone Technology CO., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fingertip Pulse Oximeter is a reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
    Device Description
    The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. M230, M230A, M230B and M230C display the measuring results on 1.3" LED screen, and the screen of M130, M130A, M130B, M130C, M160A, M160C, M170A and M170C are 0.96" OLED.
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