Infrared Thermometer, Models: YRK-002A, T8, T9, T10, T11

Thermometer, Electronic, Clinical

Yibin Junxin Electronics Technology Co., Ltd.

The following data is part of a premarket notification filed by Yibin Junxin Electronics Technology Co., Ltd. with the FDA for Infrared Thermometer, Models: Yrk-002a, T8, T9, T10, T11.

Pre-market Notification Details

Device IDK203662
510k NumberK203662
Device Name:Infrared Thermometer, Models: YRK-002A, T8, T9, T10, T11
ClassificationThermometer, Electronic, Clinical
Applicant Yibin Junxin Electronics Technology Co., Ltd. Building B2, No. 136, West Section Of Xinggang Road, Lingang Economic And Technological Devel Yibin,  CN 644000
ContactChaoze Guan
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huang District, Guangzhou, China Guangzhou,  CN 510000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-15
Decision Date2021-09-23

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