FDA 510(k)

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

Número K: K240648 · 2024-06-05

Data da decisão2024-06-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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