DT100 Digital Thermometer

Thermometer, Electronic, Clinical

Smart Technology Co., Ltd.

The following data is part of a premarket notification filed by Smart Technology Co., Ltd. with the FDA for Dt100 Digital Thermometer.

Pre-market Notification Details

Device IDK203731
510k NumberK203731
Device Name:DT100 Digital Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Smart Technology Co., Ltd. No. 8 Xingcheng East Road, Fuwan Industrial Area, Gaoming District Foshan,  CN 528500
ContactMeg Mei
CorrespondentYulan Gao
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou,  CN 510006
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2021-09-26

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