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510(k) Data Aggregation
K Number
K202591Device Name
Body Infrared Thermometer HT-820D
Manufacturer
Date Cleared
2021-03-09
(182 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Xintai Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HT-820D Body Infrared Thermometer is intended to measure human body temperature by measuring the forehead from a distance of 5-8 cm. The device can be used on the home and professional healthcare facilities.
Device Description
The Infrared thermometer is an electronic thermometer using an infrared sensor to detect human body temperature by measuring forehead. The device can be used on people of all ages.
The Infrared thermometer has the following features
- 1 Non-Contact Design.
- 2 Quick results response time less than 1 second.
- Memory function; Memory recall of 34 reading. 3
- 4) Switching between mute and un-mute.
- கு Switching between Fahrenheit and Celsius.
- Power management: auto power off; power display; low power reminder 6
- (7) Automatically power-off, if no operation for 7 seconds.
- Different temperature range display different backlight, over 37.5℃ signals warning tone (8)
- இ Prompt for high temperature.
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