Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

K-Number: K161933 · 2016-08-16

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2016-08-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a medical device manufactured by Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2016-08-16 under approval number K161933. 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 The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-16. It is manufactured by Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K161933.

When was The Braun ThermoScan® 3 High Speed Compact Ear Thermometer approved by the FDA?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer received FDA 510(k) clearance on 2016-08-16, under approval number K161933.

What company makes The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is manufactured by Kaz USA, Inc., A Helen of Troy Company.

What is the FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear Thermometer?

The FDA product code for The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is FLL.

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

K152975VDT985US Vicks SmartTemp Thermometer K163516Braun No Touch + Forehead NTF3000 Thermometer K180131Vicks RapidRead Digital Thermometer K181242Braun BNT400 No Touch + Forehead Thermometer K181015Braun BFH175 Infrared Forehead Thermometer K193213Vicks VNT200 No Touch Forehead Thermometer

View all 8 devices →

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.

↑