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510(k) Data Aggregation

    K Number
    K203170
    Device Name
    Infrared Thermometer Models: DT-8806S, DT-8807S
    Date Cleared
    2021-04-16

    (175 days)

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

    Shenzhen Everbest Machinery Industry Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
    Device Description
    The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use. The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.
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    K Number
    K101736
    Device Name
    NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
    Date Cleared
    2010-07-06

    (15 days)

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

    SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear –interference ~free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring human body's temperature with precision helps detect and observe human states of health, in case of any possible illness. Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device.
    Device Description
    Infrared Thermometer Model:DT-8806/DT-8806H/DT-886 is hand-held, reusable, battery operated.The device that can measures human body temperature by ways: 1. on forehead,the skin temperature on one's forehead(DT-8806H/DT-8806); 2.In ear.The tympanic temperature in one's ear(DT-886). The operation principle is based on Infrared Sensor technology.IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR Sensor to a digital Value and display it by LCD.
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