FDA 510(k)

퍼퓨지고 플러스

K-번호: K221627 · 2023-01-19

결정일2023-01-19

제품 코드LLZ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

PerfusionGo Plus is the device name listed in this FDA 510(k) record. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K221627. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PerfusionGo Plus?

PerfusionGo Plus is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. The 510(k) number is K221627.

When did PerfusionGo Plus receive FDA 510(k) clearance?

PerfusionGo Plus received FDA 510(k) clearance on 2023-01-19, under 510(k) number K221627.

Who is the listed applicant for PerfusionGo Plus?

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

What is the FDA product code for PerfusionGo Plus?

The FDA product code for PerfusionGo Plus is LLZ.

Yukun (Beijing) Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K213986cerebralgo plus

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