Infrared Ear And Forehead Thermometer, Model YI-100

Thermometer, Electronic, Clinical

Wenzhou Yosun Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Wenzhou Yosun Medical Technology Co., Ltd. with the FDA for Infrared Ear And Forehead Thermometer, Model Yi-100.

Pre-market Notification Details

Device IDK201843
510k NumberK201843
Device Name:Infrared Ear And Forehead Thermometer, Model YI-100
ClassificationThermometer, Electronic, Clinical
Applicant Wenzhou Yosun Medical Technology Co., Ltd. No. 17, Shahong Road, Lingmen, Beibaixiang Town, Yueqing Wenzhou,  CN 325603
ContactLihao Yang
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1813#, Gebu Commerical Building, Hongxing Community, Songgang Street Shenzhen,  CN 518000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-10-23

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