Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K152640
    Device Name
    Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT)
    Manufacturer
    FUDAKANG INDUSTRIES CO., LTD
    Date Cleared
    2016-03-28

    (195 days)

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

    FUDAKANG INDUSTRIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer (FT-F11-BT) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population. Infrared Thermometers (FT-F21-BT, FT-F41-BT) are intended for intermittent measurement of human body temperature in people of all ages.
    Device Description
    Not Found
    Ask a Question
    K Number
    K101387
    Device Name
    DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
    Manufacturer
    FUDAKANG INDUSTRIES CO., LTD
    Date Cleared
    2010-08-03

    (77 days)

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

    FUDAKANG INDUSTRIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. BT-A11CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
    Device Description
    Fudakang digital thermometers are hand-held, reusable, battery operated. The models include BT-A11CN, BT-A21CN, and BT-A41CN. All the models have the same indication for use. The difference points are their shapes, colors, voice function, and measurement speed. The operation principle 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. The digital thermometer comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result.
    Ask a Question

    Page 1 of 1