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510(k) Data Aggregation
K Number
K171578Device Name
Infrared thermometer
Manufacturer
Shenzhen Aeon Technology Co.,Ltd.
Date Cleared
2017-11-30
(183 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Aeon Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages.
The Infrared thermometer model A201 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode or Forehead mode for people of all ages.
Device Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The thermometers use 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, and an infrared distance sensor for detection of contact or no-contact use and compensation of the temperature reading.
The device consists of the MCU, enclosure and LED and the device is powered by 2 AAA alkaline batteries.
The device has a memory function that automatically stores 25 sets data of the latest measurements. It can also display the latest measurement result.
The Infrared thermometer included A200 & A201. A200 unit is a no- contact Infrared forehead thermometer, A201 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode.
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