MFG-05
K号: K230780 · 2023-10-05
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决定日期2023-10-05
产品代码KPI
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
MFG-05 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230780. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MFG-05?
MFG-05 is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K230780.
When did MFG-05 receive FDA 510(k) clearance?
MFG-05 received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230780.
Who is the listed applicant for MFG-05?
The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MFG-05?
The FDA product code for MFG-05 is KPI.
列明Zimmer Medizinsysteme GmbH为申报人的其他记录
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：KPI）
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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