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FDA 510(k)

RII Smart IR Thermometer

K-Number: K163601 · 2018-12-06

ApplicantRadiant Innovation, Inc.
Decision Date2018-12-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RII Smart IR Thermometer is a medical device manufactured by Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K163601. 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 RII Smart IR Thermometer?

RII Smart IR Thermometer is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Radiant Innovation, Inc.. The 510(k) number is K163601.

When was RII Smart IR Thermometer approved by the FDA?

RII Smart IR Thermometer received FDA 510(k) clearance on 2018-12-06, under approval number K163601.

What company makes RII Smart IR Thermometer?

RII Smart IR Thermometer is manufactured by Radiant Innovation, Inc..

What is the FDA product code for RII Smart IR Thermometer?

The FDA product code for RII Smart IR Thermometer is FLL.

Other Devices by Radiant Innovation, Inc.

K162083RII Multi-function Infrared Thermometer, Model TH52Z K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)

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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