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FDA 510(k)

YUWELL Infrared Thermometer

K-Number: K201864 · 2020-12-07

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2020-12-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YUWELL Infrared Thermometer is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2020-12-07 under approval number K201864. 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 YUWELL Infrared Thermometer?

YUWELL Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-12-07. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K201864.

When was YUWELL Infrared Thermometer approved by the FDA?

YUWELL Infrared Thermometer received FDA 510(k) clearance on 2020-12-07, under approval number K201864.

What company makes YUWELL Infrared Thermometer?

YUWELL Infrared Thermometer is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL Infrared Thermometer?

The FDA product code for YUWELL Infrared Thermometer is FLL.

Other Devices by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D K200939Electronic Blood Pressure Monitor K203583YUWELL infrared ear thermometer: YHT101, YHT200 K221372YUWELL Electronic Blood Pressure Monitor K212385YUWELL Finger Pulse Oximeter K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

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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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