FDA 510(k)

Sunsphere

Número K: K232934 · 2024-05-30

RequerenteHangzhou Yangshun Medical Technology Co.,Ltd

Data da decisão2024-05-30

Código do produtoKRD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sunsphere is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Yangshun Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-05-30 under 510(k) number K232934. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sunsphere?

Sunsphere is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Hangzhou Yangshun Medical Technology Co.,Ltd. The 510(k) number is K232934.

When did Sunsphere receive FDA 510(k) clearance?

Sunsphere received FDA 510(k) clearance on 2024-05-30, under 510(k) number K232934.

Who is the listed applicant for Sunsphere?

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

What is the FDA product code for Sunsphere?

The FDA product code for Sunsphere is KRD.

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