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FDA 510(k)

Braun BFH175 Infrared Forehead Thermometer

K-Number: K181015 · 2018-07-18

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2018-07-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Braun BFH175 Infrared Forehead Thermometer is a medical device manufactured by Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2018-07-18 under approval number K181015. 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 Braun BFH175 Infrared Forehead Thermometer?

Braun BFH175 Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-07-18. It is manufactured by Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K181015.

When was Braun BFH175 Infrared Forehead Thermometer approved by the FDA?

Braun BFH175 Infrared Forehead Thermometer received FDA 510(k) clearance on 2018-07-18, under approval number K181015.

What company makes Braun BFH175 Infrared Forehead Thermometer?

Braun BFH175 Infrared Forehead Thermometer is manufactured by Kaz USA, Inc., A Helen of Troy Company.

What is the FDA product code for Braun BFH175 Infrared Forehead Thermometer?

The FDA product code for Braun BFH175 Infrared Forehead Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Kaz USA, Inc., A Helen of Troy Company

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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. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

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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