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FDA 510(k)

Infrared Forehead Thermometer

K-Number: K201536 · 2021-02-10

ApplicantHangzhou Qingyuan Medical Equipment Technology Co., Ltd.
Decision Date2021-02-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer is a medical device manufactured by Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-10 under approval number K201536. 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?

Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2021-02-10. It is manufactured by Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.. The 510(k) number is K201536.

When was Infrared Forehead Thermometer approved by the FDA?

Infrared Forehead Thermometer received FDA 510(k) clearance on 2021-02-10, under approval number K201536.

What company makes Infrared Forehead Thermometer?

Infrared Forehead Thermometer is manufactured by Hangzhou Qingyuan Medical Equipment Technology Co., Ltd..

What is the FDA product code for Infrared Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

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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