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FDA 510(k)

EPI K 控制台

K号: K172994 · 2017-10-26

申请人Moria SA
决定日期2017-10-26
产品代码HNO
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

EPI K Console is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K172994. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EPI K Console?

EPI K Console is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Moria SA. The 510(k) number is K172994.

When did EPI K Console receive FDA 510(k) clearance?

EPI K Console received FDA 510(k) clearance on 2017-10-26, under 510(k) number K172994.

Who is the listed applicant for EPI K Console?

The FDA 510(k) record lists Moria SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPI K Console?

The FDA product code for EPI K Console is HNO.

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:HNO)

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

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