FDA 510(k)

Dual Mode Infrared Thermometer

K-Number: K163256 · 2017-04-06

Decision Date2017-04-06

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Dual Mode Infrared Thermometer is a medical device manufactured by Intelliworks, LLC. It received FDA 510(k) clearance on 2017-04-06 under approval number K163256. 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 Dual Mode Infrared Thermometer?

Dual Mode Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Intelliworks, LLC. The 510(k) number is K163256.

When was Dual Mode Infrared Thermometer approved by the FDA?

Dual Mode Infrared Thermometer received FDA 510(k) clearance on 2017-04-06, under approval number K163256.

What company makes Dual Mode Infrared Thermometer?

Dual Mode Infrared Thermometer is manufactured by Intelliworks, LLC.

What is the FDA product code for Dual Mode Infrared Thermometer?

The FDA product code for Dual Mode 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.