FDA 510(k)

Infrared Thermometer TET-351

K-Number: K220276 · 2023-02-17

Decision Date2023-02-17

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer TET-351 is a medical device manufactured by Truly Instrument Limited. It received FDA 510(k) clearance on 2023-02-17 under approval number K220276. 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 Infrared Thermometer TET-351?

Infrared Thermometer TET-351 is a medical device that received FDA 510(k) clearance on 2023-02-17. It is manufactured by Truly Instrument Limited. The 510(k) number is K220276.

When was Infrared Thermometer TET-351 approved by the FDA?

Infrared Thermometer TET-351 received FDA 510(k) clearance on 2023-02-17, under approval number K220276.

What company makes Infrared Thermometer TET-351?

Infrared Thermometer TET-351 is manufactured by Truly Instrument Limited.

What is the FDA product code for Infrared Thermometer TET-351?

The FDA product code for Infrared Thermometer TET-351 is FLL.

Other Devices by Truly Instrument Limited

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.