FDA 510(k)

Sunsphere

K-번호: K232934 · 2024-05-30

신청자Hangzhou Yangshun Medical Technology Co.,Ltd

결정일2024-05-30

제품 코드KRD

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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Sunsphere

기기 요약

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관련 임상시험

관련 기기 (코드: KRD)

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