FDA 510(k)

RealNow

Número K: K213891 · 2023-02-24

RequerenteYiwei Medical Technology Co., Ltd.

Data da decisão2023-02-24

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RealNow is the device name listed in this FDA 510(k) record. The listed applicant is Yiwei Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K213891. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RealNow?

RealNow is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Yiwei Medical Technology Co., Ltd.. The 510(k) number is K213891.

When did RealNow receive FDA 510(k) clearance?

RealNow received FDA 510(k) clearance on 2023-02-24, under 510(k) number K213891.

Who is the listed applicant for RealNow?

The FDA 510(k) record lists Yiwei Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RealNow?

The FDA product code for RealNow is LLZ.

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