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FDA 510(k)

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

K-Number: K203747 · 2021-01-25

ApplicantUni-Trend Technology (China) Co., Ltd.
Decision Date2021-01-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device manufactured by Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-25 under approval number K203747. 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 Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device that received FDA 510(k) clearance on 2021-01-25. It is manufactured by Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203747.

When was Non-Contact Forehead Thermometer (Models UT306H & UT308H) approved by the FDA?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) received FDA 510(k) clearance on 2021-01-25, under approval number K203747.

What company makes Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is manufactured by Uni-Trend Technology (China) Co., Ltd..

What is the FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

The FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H) is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING NCT06718764 Neurosteer Bedside Monitoring System RECRUITING

Other Devices by Uni-Trend Technology (China) Co., Ltd.

K203656Non-Contact Forehead Thermometer (UT30H)

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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