Infrared Forehead Thermometer

Thermometer, Electronic, Clinical

Shenzhen Combei Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Combei Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer.

Pre-market Notification Details

Device IDK202741
510k NumberK202741
Device Name:Infrared Forehead Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Combei Technology Co., Ltd. No. 105, Huanguan South Road, Dahe Community, Guanlan, Long Hua New Distri Shenzhen,  CN 518110
ContactKevin Fong
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-18
Decision Date2021-07-07

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