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510(k) Data Aggregation

    K Number
    K211532
    Device Name
    Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
    Date Cleared
    2022-01-19

    (246 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yibin Junxin Electronics Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Arm Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~36 cm.
    Device Description
    The Arm Blood Pressure Monitor is a battery powered automatic non-invasive pressure monitor, powered by 4 x1.5V AAA battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function for data reviewing. The proposed Arm Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The product is provided non-sterile, and not to be sterilized by the user prior to use.
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    K Number
    K203662
    Device Name
    Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
    Date Cleared
    2021-09-23

    (282 days)

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

    Yibin Junxin Electronics Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.
    Device Description
    Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead temperature when measure from 2-5 cm of the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings. lt composed by a measuring sensor, PCB, 4 buttons, an LCD and an enclosure. The functions of the five models are same. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power status, measurement mode, temperature unit and measurement temperature. Press the "Setting" key to open the F1: The function of "Temperature Unit" can be set. When measuring body temperature, users need to measure in body mode from 2-5 cm from their forehead. Press the trigger, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 17 sec. The difference between these models is only the model's name.
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