视界监测仪 - MonpackONE
K号: K211643 · 2021-07-26
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申请人Metrovision
决定日期2021-07-26
产品代码GWE
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Vision Monitor - MonpackONE is the device name listed in this FDA 510(k) record. The listed applicant is Metrovision. It received FDA 510(k) clearance on 2021-07-26 under 510(k) number K211643. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vision Monitor - MonpackONE?
Vision Monitor - MonpackONE is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Metrovision. The 510(k) number is K211643.
When did Vision Monitor - MonpackONE receive FDA 510(k) clearance?
Vision Monitor - MonpackONE received FDA 510(k) clearance on 2021-07-26, under 510(k) number K211643.
Who is the listed applicant for Vision Monitor - MonpackONE?
The FDA 510(k) record lists Metrovision as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vision Monitor - MonpackONE?
The FDA product code for Vision Monitor - MonpackONE is GWE.
相关临床试验
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列明Metrovision为申报人的其他记录
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相关器械（代码：GWE）
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。
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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