Infrared Thermometer

Thermometer, Electronic, Clinical

Contec Medical Systems Co., Ltd.

The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Infrared Thermometer.

Pre-market Notification Details

Device IDK201980
510k NumberK201980
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao,  CN 066004
ContactXueyong Li
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District,  CN 102401
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-16
Decision Date2020-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000
06945040105428 K201980 000

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