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FDA 510(k)

EZYPOR

K号: K212741 · 2022-06-24

决定日期2022-06-24
产品代码HPZ
咨询委员会OP 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

EZYPOR is the device name listed in this FDA 510(k) record. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K212741. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EZYPOR?

EZYPOR is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K212741.

When did EZYPOR receive FDA 510(k) clearance?

EZYPOR received FDA 510(k) clearance on 2022-06-24, under 510(k) number K212741.

Who is the listed applicant for EZYPOR?

The FDA 510(k) record lists Fci (France Chirurgie Instrumentation) Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZYPOR?

The FDA product code for EZYPOR is HPZ.

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。

列明Fci (France Chirurgie Instrumentation) Sas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。

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