Infrared Forehead Thermometer (Model IR-FT)

Thermometer, Electronic, Clinical

Comper Chuangxiang (Beijing) Technology Co., Ltd.

The following data is part of a premarket notification filed by Comper Chuangxiang (beijing) Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer (model Ir-ft).

Pre-market Notification Details

Device IDK191668
510k NumberK191668
Device Name:Infrared Forehead Thermometer (Model IR-FT)
ClassificationThermometer, Electronic, Clinical
Applicant Comper Chuangxiang (Beijing) Technology Co., Ltd. Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District,  CN 100176
ContactHan Du
CorrespondentHan Du
Comper Chuangxiang (Beijing) Technology Co., Ltd. Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District,  CN 100176
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-21
Decision Date2019-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970528391109 K191668 000
06974415521105 K191668 000

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