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510(k) Data Aggregation

    K Number
    K211143
    Device Name
    Pulse Oximeter
    Date Cleared
    2023-07-17

    (822 days)

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

    Shenzhen brav electronic technologies co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
    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 subjected 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.OP-101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of OP-102 and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on OP-102 and OP-103. The subjected device is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
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    K Number
    K171214
    Device Name
    Infrared Thermometer
    Date Cleared
    2018-03-02

    (311 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Brav Electronic Technologies Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
    Device Description
    EFT-16 series (Model: EFT-161, EFT-162, EFT-164, EFT-165, EFT-166) measure the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, and ear temperature mode, directly show on the LCD screen. The device is widely used for home healthcare, medical institutes and many other occasions. The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. It focuses the infrared from the human's forehead or ear by the Fresnel lens.
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