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FDA 510(k)

Infrared Thermometer

K-Number: K201579 · 2021-01-15

ApplicantShenzhen Xunwei Industrial Co., Ltd.
Decision Date2021-01-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer is a medical device manufactured by Shenzhen Xunwei Industrial Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under approval number K201579. 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 Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Shenzhen Xunwei Industrial Co., Ltd.. The 510(k) number is K201579.

When was Infrared Thermometer approved by the FDA?

Infrared Thermometer received FDA 510(k) clearance on 2021-01-15, under approval number K201579.

What company makes Infrared Thermometer?

Infrared Thermometer is manufactured by Shenzhen Xunwei Industrial Co., Ltd..

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

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

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

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