Digital Thermometer

Thermometer, Electronic, Clinical

Joytech Healthcare Co., Ltd

The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd with the FDA for Digital Thermometer.

Pre-market Notification Details

Device IDK200599
510k NumberK200599
Device Name:Digital Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Joytech Healthcare Co., Ltd No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
ContactRen Yunhua
CorrespondentRen Yunhua
Joytech Healthcare Co., Ltd No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou,  CN 311100
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-07-08

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