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FDA 510(k)

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)

K-Number: K240648 · 2024-06-05

ApplicantRadiant Innovation, Inc.
Decision Date2024-06-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is a medical device manufactured by Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2024-06-05 under approval number K240648. 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 Thermomete (TH48FE, TH09F, THD2FE)?

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is a medical device that received FDA 510(k) clearance on 2024-06-05. It is manufactured by Radiant Innovation, Inc.. The 510(k) number is K240648.

When was Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) approved by the FDA?

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) received FDA 510(k) clearance on 2024-06-05, under approval number K240648.

What company makes Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is manufactured by Radiant Innovation, Inc..

What is the FDA product code for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

The FDA product code for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is FLL.

Related Clinical Trials

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

Other Devices by Radiant Innovation, Inc.

K162083RII Multi-function Infrared Thermometer, Model TH52Z K163601RII Smart IR Thermometer

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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