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510(k) Data Aggregation

    K Number
    K232473
    Device Name
    Infrared Thermometer: Model YJ600
    Date Cleared
    2024-02-09

    (177 days)

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

    Zhuhai Yueja Medical Device Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
    Device Description
    Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.
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    K Number
    K232815
    Device Name
    Wrist Blood Pressure Monitor
    Date Cleared
    2023-12-11

    (89 days)

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

    Zhuhai Yueja Medical Device Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
    Device Description
    Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case. Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. The Wrist Blood Pressure Monitor include two models: YJ110, YJ111
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    K Number
    K232814
    Device Name
    Electronic Blood Pressure Monitor
    Date Cleared
    2023-12-05

    (83 days)

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

    Zhuhai Yueja Medical Device Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.
    Device Description
    Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.
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