GERDX-系统
K号: K233240 · 2024-06-21
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申请人G-Surg GmbH
决定日期2024-06-21
产品代码ODE
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
GERDX-System is the device name listed in this FDA 510(k) record. The listed applicant is G-Surg GmbH. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233240. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GERDX-System?
GERDX-System is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is G-Surg GmbH. The 510(k) number is K233240.
When did GERDX-System receive FDA 510(k) clearance?
GERDX-System received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233240.
Who is the listed applicant for GERDX-System?
The FDA 510(k) record lists G-Surg GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GERDX-System?
The FDA product code for GERDX-System is ODE.
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：ODE）
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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