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FDA 510(k)

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

K-Number: K250878 · 2025-05-22

ApplicantJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision Date2025-05-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) is a medical device manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under approval number K250878. 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 Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)?

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) is a medical device that received FDA 510(k) clearance on 2025-05-22. It is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K250878.

When was YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) approved by the FDA?

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) received FDA 510(k) clearance on 2025-05-22, under approval number K250878.

What company makes YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)?

YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) is manufactured by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

What is the FDA product code for YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)?

The FDA product code for YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) 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 K201864YUWELL Infrared Thermometer K200939Electronic Blood Pressure Monitor K203583YUWELL infrared ear thermometer: YHT101, YHT200 K221372YUWELL Electronic Blood Pressure Monitor K212385YUWELL Finger Pulse Oximeter

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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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