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FDA 510(k)

Digital thermometer(with disposable thermometer cover)

K-Number: K172861 · 2017-12-19

ApplicantHangzhou Hua'An Medical&Health Instruments Co.,Ltd
Decision Date2017-12-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital thermometer(with disposable thermometer cover) is a medical device manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. It received FDA 510(k) clearance on 2017-12-19 under approval number K172861. 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 Digital thermometer(with disposable thermometer cover)?

Digital thermometer(with disposable thermometer cover) is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K172861.

When was Digital thermometer(with disposable thermometer cover) approved by the FDA?

Digital thermometer(with disposable thermometer cover) received FDA 510(k) clearance on 2017-12-19, under approval number K172861.

What company makes Digital thermometer(with disposable thermometer cover)?

Digital thermometer(with disposable thermometer cover) is manufactured by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd.

What is the FDA product code for Digital thermometer(with disposable thermometer cover)?

The FDA product code for Digital thermometer(with disposable thermometer cover) is FLL.

Other Devices by Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

K160999Infra-red forehead thermometer K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

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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