EnlightenVue 微型内窥镜系统
K号: K192300 · 2020-03-20
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决定日期2020-03-20
产品代码GCJ
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
EnlightenVue Microendoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Enlightenvue, Inc.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192300. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EnlightenVue Microendoscopy System?
EnlightenVue Microendoscopy System is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Enlightenvue, Inc.. The 510(k) number is K192300.
When did EnlightenVue Microendoscopy System receive FDA 510(k) clearance?
EnlightenVue Microendoscopy System received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192300.
Who is the listed applicant for EnlightenVue Microendoscopy System?
The FDA 510(k) record lists Enlightenvue, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EnlightenVue Microendoscopy System?
The FDA product code for EnlightenVue Microendoscopy System is GCJ.
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：GCJ）
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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