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FDA 510(k)

Infrared Forehead Thermometer (Model IR-FT)

K-Number: K191668 · 2019-10-18

ApplicantComper Chuangxiang (Beijing) Technology Co., Ltd.
Decision Date2019-10-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer (Model IR-FT) is a medical device manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-18 under approval number K191668. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infrared Forehead Thermometer (Model IR-FT)?

Infrared Forehead Thermometer (Model IR-FT) is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K191668.

When was Infrared Forehead Thermometer (Model IR-FT) approved by the FDA?

Infrared Forehead Thermometer (Model IR-FT) received FDA 510(k) clearance on 2019-10-18, under approval number K191668.

What company makes Infrared Forehead Thermometer (Model IR-FT)?

Infrared Forehead Thermometer (Model IR-FT) is manufactured by Comper Chuangxiang (Beijing) Technology Co., Ltd..

What is the FDA product code for Infrared Forehead Thermometer (Model IR-FT)?

The FDA product code for Infrared Forehead Thermometer (Model IR-FT) is FLL.

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Other Devices by Comper Chuangxiang (Beijing) Technology Co., Ltd.

K202481ThermArt (Model IR-EFT)

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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