Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

Thermometer, Electronic, Clinical

Guandong Genial Technology CO., LIMITED

The following data is part of a premarket notification filed by Guandong Genial Technology Co., Limited with the FDA for Infrared Forehead Thermometer (model: T80, T81, T82, T83, T84, T85).

Pre-market Notification Details

Device IDK210014
510k NumberK210014
Device Name:Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
ClassificationThermometer, Electronic, Clinical
Applicant Guandong Genial Technology CO., LIMITED I-6-05-02, 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town Zhaoqing,  CN
ContactJun Yu
CorrespondentJet Li
Guangzhou KINDA Biology Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-06-04

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