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FDA 510(k)

ICE 压缩第一、二、三系统

K号: K193079 · 2021-01-11

申请人Mks Paris
决定日期2021-01-11
产品代码IRP
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

ICE COMPRESSION FIRST, DUO, & MOOVE Systems is the device name listed in this FDA 510(k) record. The listed applicant is Mks Paris. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K193079. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

ICE COMPRESSION FIRST, DUO, & MOOVE Systems is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Mks Paris. The 510(k) number is K193079.

When did ICE COMPRESSION FIRST, DUO, & MOOVE Systems receive FDA 510(k) clearance?

ICE COMPRESSION FIRST, DUO, & MOOVE Systems received FDA 510(k) clearance on 2021-01-11, under 510(k) number K193079.

Who is the listed applicant for ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

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

What is the FDA product code for ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

The FDA product code for ICE COMPRESSION FIRST, DUO, & MOOVE Systems is IRP.

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:IRP)

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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