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510(k) Data Aggregation
K Number
K243082Device Name
Infrared Thermometer
Manufacturer
Guangzhou Daxin Health Technology Co., Ltd
Date Cleared
2025-04-25
(207 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Daxin Health Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For T30: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.
For TE-82: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.
For TE-102 and TE-79: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.
Device Description
The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead.
The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display.
The results of measurements can also be transferred to the APP via Bluetooth for recording and display
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