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510(k) Data Aggregation
K Number
K171214Device Name
Infrared Thermometer
Manufacturer
Shenzhen Brav Electronic Technologies Co., Ltd.
Date Cleared
2018-03-02
(311 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Brav Electronic Technologies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
Device Description
EFT-16 series (Model: EFT-161, EFT-162, EFT-164, EFT-165, EFT-166) measure the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, and ear temperature mode, directly show on the LCD screen. The device is widely used for home healthcare, medical institutes and many other occasions. The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc. It focuses the infrared from the human's forehead or ear by the Fresnel lens.
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