Infrared Thermometer

Thermometer, Electronic, Clinical

Shenzhen Urion Technology Co., Ltd

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

Pre-market Notification Details

Device IDK200802
510k NumberK200802
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Urion Technology Co., Ltd 4-6F Of Building D, Jiale Science& Technology Industrial Zone, Heshuikou Comm Shenzhen,  CN 518106
ContactAutumn Liu
CorrespondentChangming Zhu
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen,  CN 518105
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-27
Decision Date2020-10-07

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