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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 the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2024-06-05 under 510(k) 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. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K240648.

When did Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) receive FDA 510(k) clearance?

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

Who is the listed applicant for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

The FDA 510(k) record lists Radiant Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Radiant Innovation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163601RII Smart IR ThermometerK162083RII Multi-function Infrared Thermometer, Model TH52Z

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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.

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