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510(k) Data Aggregation
K Number
K200781Device Name
Infrared Body Thermometer
Manufacturer
Date Cleared
2020-12-09
(273 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
HeiTaiDa Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
Device Description
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
The device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.
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