Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K190982
    Device Name
    Automatic Digital Blood Pressure Monitor
    Manufacturer
    Xiamen Ants Bro Technology Co., Ltd.
    Date Cleared
    2020-05-29

    (410 days)

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

    Xiamen Ants Bro Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Automatic Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm. It can be used at medical facilities or at home. The intended wrist circumference is 12.5~20 cm and the intended arm circumference has several models: 23~33 cm, 25~35 cm, 22~42 cm, 33~43 cm.
    Device Description
    Automatic Digital 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 via non-invasive Oscillometric technique in which an inflatable cuff is wrapped around the wrist or the upper arm.It can be used at medical facilities or at home. The Automatic Digital Blood Pressure Monitor main units have the operating elements of ON/OFF knob, SET key which can be user-friendly controlled. Arm type Blood Pressure Monitor is equipped with inflatable cuff, while The wrist type Blood Pressure Monitor`s cuff is attached to the device body itself.
    Ask a Question
    K Number
    K190984
    Device Name
    Infrared Forehead Thermometer
    Manufacturer
    Xiamen Ants Bro Technology Co., Ltd.
    Date Cleared
    2020-04-22

    (373 days)

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

    Xiamen Ants Bro Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is a non-sterile, reusable, clinical thermometer intent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.
    Device Description
    The Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-640, HA-650) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings. It composed by a measuring sensor, set button, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
    Ask a Question
    K Number
    K190990
    Device Name
    Digital Thermometer
    Manufacturer
    Xiamen Ants Bro Technology Co., Ltd.
    Date Cleared
    2019-12-31

    (260 days)

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

    Xiamen Ants Bro Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Thermometer (models TM-2011, TM-3002, TM-3102) intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
    Device Description
    Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD. There is buzzing noise occurs when the device turns on and when the measurement is completed (for model TM-3002 and TM-3102 only.
    Ask a Question

    Page 1 of 1