Infrared Forehead Thermometer

Thermometer, Electronic, Clinical

Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.

The following data is part of a premarket notification filed by Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer.

Pre-market Notification Details

Device IDK201536
510k NumberK201536
Device Name:Infrared Forehead Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. No.688 Dong'an 1st Road, Xintang Street, Xaioshan District Hangzhou,  CN 311200
ContactJenny Li
CorrespondentYoyo Chen
Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen,  CN 518000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2021-02-10

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