FDA 510(k)

Infrared thermometer

K-Number: K171578 · 2017-11-30

ApplicantShenzhen Aeon Technology Co., Ltd.

Decision Date2017-11-30

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Infrared thermometer is a medical device manufactured by Shenzhen Aeon Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-30 under approval number K171578. 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 2017-11-30. It is manufactured by Shenzhen Aeon Technology Co., Ltd.. The 510(k) number is K171578.

When was Infrared thermometer approved by the FDA?

Infrared thermometer received FDA 510(k) clearance on 2017-11-30, under approval number K171578.

What company makes Infrared thermometer?

Infrared thermometer is manufactured by Shenzhen Aeon Technology Co., Ltd..

What is the FDA product code for Infrared thermometer?

The FDA product code for Infrared thermometer is FLL.

Other Devices by Shenzhen Aeon Technology Co., Ltd.

K190869Pulse Oximeter K200414Pulse Oximeter

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.