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FDA 510(k)

RII Multi-function Infrared Thermometer, Model TH52Z

K-Number: K162083 · 2017-01-09

ApplicantRadiant Innovation, Inc.
Decision Date2017-01-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RII Multi-function Infrared Thermometer, Model TH52Z is a medical device manufactured by Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2017-01-09 under approval number K162083. 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 Multi-function Infrared Thermometer, Model TH52Z?

RII Multi-function Infrared Thermometer, Model TH52Z is a medical device that received FDA 510(k) clearance on 2017-01-09. It is manufactured by Radiant Innovation, Inc.. The 510(k) number is K162083.

When was RII Multi-function Infrared Thermometer, Model TH52Z approved by the FDA?

RII Multi-function Infrared Thermometer, Model TH52Z received FDA 510(k) clearance on 2017-01-09, under approval number K162083.

What company makes RII Multi-function Infrared Thermometer, Model TH52Z?

RII Multi-function Infrared Thermometer, Model TH52Z is manufactured by Radiant Innovation, Inc..

What is the FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z?

The FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z is FLL.

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Related PubMed Literature

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Other Devices by Radiant Innovation, Inc.

K163601RII Smart IR Thermometer 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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