Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210118
    Device Name
    INFRARED BODY THERMOMETER (Model: YK-001)
    Date Cleared
    2021-09-15

    (239 days)

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

    Longnan RenZhong Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.
    Device Description
    The proposed device, INFRARED BODY THERMOMETER, which includes model YK-001 hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead. The proposed device measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the human forehead temperature, object temperature and environment temperature; 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. The device has the following features: About two-second measuring time, measuring Body or Ambient temperature, 99-memory recalls, degree C/degree F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen. The device will display 3 different background colors according to the result. The power supply of INFRARED BODY THERMOMETER (YK-001) is 3.0V DC, it is powered by two AAA batteries. The reference body site of INFRARED BODY THERMOMETER (Model: YK-001) is armpit.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1