EndoScreener
K号: K211326 · 2021-11-19
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决定日期2021-11-19
产品代码QNP
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：QNP）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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