FDA 510(k)

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K-번호: K211326 · 2021-11-19

신청자Chengdu Wision Medical Device Co., Ltd.

결정일2021-11-19

제품 코드QNP

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

EndoScreener is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211326. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EndoScreener?

EndoScreener is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. The 510(k) number is K211326.

When did EndoScreener receive FDA 510(k) clearance?

EndoScreener received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211326.

Who is the listed applicant for EndoScreener?

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

What is the FDA product code for EndoScreener?

The FDA product code for EndoScreener is QNP.

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기기 요약

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관련 임상시험

관련 기기 (코드: QNP)

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