FDA 510(k)

SilentZPro 2.0

Número K: K220688 · 2022-12-02

Data da decisão2022-12-02

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SilentZPro 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Shinrin-Yoku Traders, LLC. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K220688. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SilentZPro 2.0?

SilentZPro 2.0 is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Shinrin-Yoku Traders, LLC. The 510(k) number is K220688.

When did SilentZPro 2.0 receive FDA 510(k) clearance?

SilentZPro 2.0 received FDA 510(k) clearance on 2022-12-02, under 510(k) number K220688.

Who is the listed applicant for SilentZPro 2.0?

The FDA 510(k) record lists Shinrin-Yoku Traders, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SilentZPro 2.0?

The FDA product code for SilentZPro 2.0 is LRK.

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Fonte oficial

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