Braun Thermoscan PRO 6000 Ear Thermometer
K-Number: K152748 · 2016-03-01
Decision Date2016-03-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Braun Thermoscan PRO 6000 Ear Thermometer is a medical device manufactured by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). It received FDA 510(k) clearance on 2016-03-01 under approval number K152748. 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 Thermoscan PRO 6000 Ear Thermometer?
Braun Thermoscan PRO 6000 Ear Thermometer is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc). The 510(k) number is K152748.
When was Braun Thermoscan PRO 6000 Ear Thermometer approved by the FDA?
Braun Thermoscan PRO 6000 Ear Thermometer received FDA 510(k) clearance on 2016-03-01, under approval number K152748.
What company makes Braun Thermoscan PRO 6000 Ear Thermometer?
Braun Thermoscan PRO 6000 Ear Thermometer is manufactured by Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc).
What is the FDA product code for Braun Thermoscan PRO 6000 Ear Thermometer?
The FDA product code for Braun Thermoscan PRO 6000 Ear Thermometer is FLL.
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.