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510(k) Data Aggregation

    K Number
    K172874
    Device Name
    Infrared Thermometer
    Manufacturer
    Shenzhen Jiacom Technology Co., Ltd
    Date Cleared
    2018-07-12

    (294 days)

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

    Shenzhen Jiacom Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.
    Device Description
    The proposed device, Infrared Thermometers, which includes model FR800 and FR850 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead for infant (above 6 months), child, adolescent, and adult. The proposed device is intended for non-contacting infrared temperature measurement. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature and temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.
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    K Number
    K172972
    Device Name
    Wrist Type Automatic Blood Pressure Monitor
    Manufacturer
    Shenzhen Jiacom Technology Co., Ltd
    Date Cleared
    2018-03-02

    (157 days)

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

    Shenzhen Jiacom Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wrist Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population who can understand the instruction manual with the wrist circumference range printed on the wrist cuff. The intended wrist circumference is 13.5-19.5 cm.
    Device Description
    The proposed device, Wrist Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist 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 in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes 5 models, which are BP165W, BP180W, BP186W and BP 188W. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
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