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FDA 510(k)

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1

K-Number: K161728 · 2016-12-05

ApplicantMicrofile Intellectual Property GmbH
Decision Date2016-12-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is a medical device manufactured by Microfile Intellectual Property GmbH. It received FDA 510(k) clearance on 2016-12-05 under approval number K161728. 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 Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Microfile Intellectual Property GmbH. The 510(k) number is K161728.

When was Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 approved by the FDA?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 received FDA 510(k) clearance on 2016-12-05, under approval number K161728.

What company makes Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is manufactured by Microfile Intellectual Property GmbH.

What is the FDA product code for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

The FDA product code for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is FLL.

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Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. 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. 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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