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FDA 510(k)

Revitive Medic Plus, Revitive Advanced 2

K号: K192887 · 2020-05-04

申请人Actegy , Ltd.
决定日期2020-05-04
产品代码NGX
咨询委员会PM 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

Revitive Medic Plus, Revitive Advanced 2 is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K192887. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Revitive Medic Plus, Revitive Advanced 2?

Revitive Medic Plus, Revitive Advanced 2 is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Actegy , Ltd.. The 510(k) number is K192887.

When did Revitive Medic Plus, Revitive Advanced 2 receive FDA 510(k) clearance?

Revitive Medic Plus, Revitive Advanced 2 received FDA 510(k) clearance on 2020-05-04, under 510(k) number K192887.

Who is the listed applicant for Revitive Medic Plus, Revitive Advanced 2?

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

What is the FDA product code for Revitive Medic Plus, Revitive Advanced 2?

The FDA product code for Revitive Medic Plus, Revitive Advanced 2 is NGX.

相关临床试验

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列明Actegy , Ltd.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:NGX)

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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