SmartBag (SmartPouch)
K号: K181643 · 2018-11-16
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决定日期2018-11-16
产品代码EXB
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
SmartBag (SmartPouch) is the device name listed in this FDA 510(k) record. The listed applicant is 11 Health Technologies Limited. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181643. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartBag (SmartPouch)?
SmartBag (SmartPouch) is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is 11 Health Technologies Limited. The 510(k) number is K181643.
When did SmartBag (SmartPouch) receive FDA 510(k) clearance?
SmartBag (SmartPouch) received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181643.
Who is the listed applicant for SmartBag (SmartPouch)?
The FDA 510(k) record lists 11 Health Technologies Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartBag (SmartPouch)?
The FDA product code for SmartBag (SmartPouch) is EXB.
相关临床试验
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相关器械（代码：EXB）
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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