Digital Thermometer

Thermometer, Electronic, Clinical

Xiamen Ants Bro Technology Co., Ltd.

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

Pre-market Notification Details

Device IDK190990
510k NumberK190990
Device Name:Digital Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Xiamen Ants Bro Technology Co., Ltd. 4th & 5th Floor, No.5 Building, Tech & Innovation Center No. 289 Wengjiao Road, Haicang District Xiamen,  CN 361026
ContactJane Xu
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou,  CN 510000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-15
Decision Date2019-12-31
Summary:summary

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