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FDA 510(k)

Braun No Touch + Forehead NTF3000 Thermometer

K-Number: K163516 · 2017-04-21

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2017-04-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Braun No Touch + Forehead NTF3000 Thermometer is a medical device manufactured by Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2017-04-21 under approval number K163516. 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 No Touch + Forehead NTF3000 Thermometer?

Braun No Touch + Forehead NTF3000 Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K163516.

When was Braun No Touch + Forehead NTF3000 Thermometer approved by the FDA?

Braun No Touch + Forehead NTF3000 Thermometer received FDA 510(k) clearance on 2017-04-21, under approval number K163516.

What company makes Braun No Touch + Forehead NTF3000 Thermometer?

Braun No Touch + Forehead NTF3000 Thermometer is manufactured by Kaz USA, Inc., A Helen of Troy Company.

What is the FDA product code for Braun No Touch + Forehead NTF3000 Thermometer?

The FDA product code for Braun No Touch + Forehead NTF3000 Thermometer is FLL.

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

K161933The Braun ThermoScan® 3 High Speed Compact Ear Thermometer K152975VDT985US Vicks SmartTemp Thermometer K180131Vicks RapidRead Digital Thermometer K181242Braun BNT400 No Touch + Forehead Thermometer K181015Braun BFH175 Infrared Forehead Thermometer K193213Vicks VNT200 No Touch Forehead Thermometer

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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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