Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603

Thermometer, Electronic, Clinical

ShenZhen ZhengKang Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Zhengkang Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer, Model Jzk-601, Jzk-602, Jzk-603.

Pre-market Notification Details

Device IDK203707
510k NumberK203707
Device Name:Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
ClassificationThermometer, Electronic, Clinical
Applicant ShenZhen ZhengKang Technology Co., Ltd. 2&3/F, Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street Shenzhen,  CN 518100
ContactHuayong Yang
CorrespondentIris Wang
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 Received2020-12-18
Decision Date2021-03-12

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