YUWELL Infrared Ear Thermometer: YHT101, YHT200

Thermometer, Electronic, Clinical

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd with the FDA for Yuwell Infrared Ear Thermometer: Yht101, Yht200.

Pre-market Notification Details

Device IDK203583
510k NumberK203583
Device Name:YUWELL Infrared Ear Thermometer: YHT101, YHT200
ClassificationThermometer, Electronic, Clinical
Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park, Danyang, Jiangsu, China Jiangsu,  CN 212300
ContactYuzhuo Wang
CorrespondentYuzhuo Wang
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park, Danyang, Jiangsu, China Jiangsu,  CN 212300
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-08
Decision Date2021-05-20

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