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FDA 510(k)

Infrared Forehead Thermometer, FT-100A

K-Number: K160802 · 2016-08-24

ApplicantHangzhou Universal Electronic Co., Ltd.
Decision Date2016-08-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer, FT-100A is a medical device manufactured by Hangzhou Universal Electronic Co., Ltd.. It received FDA 510(k) clearance on 2016-08-24 under approval number K160802. 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, FT-100A?

Infrared Forehead Thermometer, FT-100A is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by Hangzhou Universal Electronic Co., Ltd.. The 510(k) number is K160802.

When was Infrared Forehead Thermometer, FT-100A approved by the FDA?

Infrared Forehead Thermometer, FT-100A received FDA 510(k) clearance on 2016-08-24, under approval number K160802.

What company makes Infrared Forehead Thermometer, FT-100A?

Infrared Forehead Thermometer, FT-100A is manufactured by Hangzhou Universal Electronic Co., Ltd..

What is the FDA product code for Infrared Forehead Thermometer, FT-100A?

The FDA product code for Infrared Forehead Thermometer, FT-100A is FLL.

Related Clinical Trials

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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. K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company

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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