Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

Thermometer, Electronic, Clinical

Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. with the FDA for Infrared Forehead Thermometer, Model Lfr30b, Lfr50, Lfr60.

Pre-market Notification Details

Device IDK202687
510k NumberK202687
Device Name:Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. North Side Of Floor 3, BLD 9 BaiWangxin High-Tech Industrial Park Songbai Roa Shenzhen,  CN 518055
ContactAaron Lin
CorrespondentArthur Goddard
FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights,  OH  44124 -4445
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2021-02-18

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