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FDA 510(k)

Infrared Thermometer

K-Number: K200802 · 2020-10-07

ApplicantShenzhen Urion Technology Co., Ltd.
Decision Date2020-10-07
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer is a medical device manufactured by Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-10-07 under approval number K200802. 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?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K200802.

When was Infrared Thermometer approved by the FDA?

Infrared Thermometer received FDA 510(k) clearance on 2020-10-07, under approval number K200802.

What company makes Infrared Thermometer?

Infrared Thermometer is manufactured by Shenzhen Urion Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

Other Devices by Shenzhen Urion Technology Co., Ltd.

K160019U80 Series Upper Arm Electronic Blood Pressure Monitor K241007Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) K243115Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

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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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