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FDA 510(k)

AT-6XX Series Infrared Thermometer

K-Number: K171455 · 2018-02-09

ApplicantXiamen Acurio Instruments Co., Ltd.
Decision Date2018-02-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AT-6XX Series Infrared Thermometer is a medical device manufactured by Xiamen Acurio Instruments Co., Ltd.. It received FDA 510(k) clearance on 2018-02-09 under approval number K171455. 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 AT-6XX Series Infrared Thermometer?

AT-6XX Series Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-02-09. It is manufactured by Xiamen Acurio Instruments Co., Ltd.. The 510(k) number is K171455.

When was AT-6XX Series Infrared Thermometer approved by the FDA?

AT-6XX Series Infrared Thermometer received FDA 510(k) clearance on 2018-02-09, under approval number K171455.

What company makes AT-6XX Series Infrared Thermometer?

AT-6XX Series Infrared Thermometer is manufactured by Xiamen Acurio Instruments Co., Ltd..

What is the FDA product code for AT-6XX Series Infrared Thermometer?

The FDA product code for AT-6XX Series Infrared Thermometer is FLL.

Other Devices by Xiamen Acurio Instruments Co., Ltd.

K180685AS-3XX Series Fingertip Pulse Oximeter

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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