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510(k) Data Aggregation

    K Number
    K202741
    Device Name
    Infrared Forehead Thermometer
    Manufacturer
    Shenzhen Combei Technology Co., Ltd.
    Date Cleared
    2021-07-07

    (292 days)

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

    Shenzhen Combei Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
    Device Description
    The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.
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    K Number
    K181104
    Device Name
    Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style
    Manufacturer
    Shenzhen Combei Technology CO., LTD
    Date Cleared
    2018-08-29

    (125 days)

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

    Shenzhen Combei Technology CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heart beats during measurement and gives a warning signal with readings. The Subject device is not intended to be diagnostic device.
    Device Description
    Combei Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, Bluetooth tranismiision (optional) and the LCD. The subject devices are powered by four AA alkaline batteries or adatpter. The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irreqular pulse rhythm when the difference of the time intervals is over a specified range.
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    K Number
    K171833
    Device Name
    Digital Blood Pressure Monitor-Wrist Style
    Manufacturer
    Shenzhen Combei Technology CO., LTD
    Date Cleared
    2018-01-10

    (205 days)

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

    Shenzhen Combei Technology CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist. The Subject device is not intended to be diagnostic device.
    Device Description
    The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The wrist style utilizes an inflatable cuff that is wrapped around the single wrist; the cuff circumference is limited to: 12.5~21.5cm(4.9~8.5in).
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    K Number
    K163606
    Device Name
    Digital Blood Pressure Monitor-Automatic Upper Arm Style
    Manufacturer
    Shenzhen Combei Technology CO., LTD
    Date Cleared
    2017-05-09

    (139 days)

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

    Shenzhen Combei Technology CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff (size: 22~32cm(8.7~12.6in) is wrapped around the single upper arm. The Subject device is not intended to be diagnostic device.
    Device Description
    The Subject device is battery driven automatic non-invasive Blood Pressure Monitor. It consists of the Main Control Unit, LCD and attachments. The device can automatically complete the inflation, deflation and BP measurement, which intended to measure the diastolic, systolic blood pressures and pulse rate for an adult individual via the oscillometric technique. The Automatic Upper Arm style utilizes an inflatable cuff that is wrapped around the upper arm; the cuff circumference is limited to: 22cm~32cm (8.7in~12.6in).
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