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FDA 510(k)

Medical infrared forehead thermometer

K-Number: K202111 · 2021-02-26

ApplicantHunan Honggao Electronic Technolofy Co., Ltd.
Decision Date2021-02-26
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical infrared forehead thermometer is a medical device manufactured by Hunan Honggao Electronic Technolofy Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under approval number K202111. 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 Medical infrared forehead thermometer?

Medical infrared forehead thermometer is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Hunan Honggao Electronic Technolofy Co., Ltd.. The 510(k) number is K202111.

When was Medical infrared forehead thermometer approved by the FDA?

Medical infrared forehead thermometer received FDA 510(k) clearance on 2021-02-26, under approval number K202111.

What company makes Medical infrared forehead thermometer?

Medical infrared forehead thermometer is manufactured by Hunan Honggao Electronic Technolofy Co., Ltd..

What is the FDA product code for Medical infrared forehead thermometer?

The FDA product code for Medical infrared forehead thermometer is FLL.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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 →

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