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510(k) Data Aggregation
K Number
K210014Device Name
Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
Manufacturer
Date Cleared
2021-06-04
(151 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Guandong Genial Technology CO., LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.
Device Description
The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value.
The Infrared Forehead Thermometer (Model: T80、T81、T84、T85),consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries
The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.
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