FDA 510(k)

Infrared Heat (Model: E0221)

Número K: K223893 · 2023-05-16

RequerenteLight Tree Ventures Europe B.V.

Data da decisão2023-05-16

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Heat (Model: E0221) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K223893. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infrared Heat (Model: E0221)?

Infrared Heat (Model: E0221) is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K223893.

When did Infrared Heat (Model: E0221) receive FDA 510(k) clearance?

Infrared Heat (Model: E0221) received FDA 510(k) clearance on 2023-05-16, under 510(k) number K223893.

Who is the listed applicant for Infrared Heat (Model: E0221)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Heat (Model: E0221)?

The FDA product code for Infrared Heat (Model: E0221) is OHS.

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Fonte oficial

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