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FDA 510(k)

Aquilo Sports CCT1500 System

K号: K223164 · 2022-11-04

申请人Aquilo Sports, LLC
决定日期2022-11-04
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

Aquilo Sports CCT1500 System is the device name listed in this FDA 510(k) record. The listed applicant is Aquilo Sports, LLC. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K223164. 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 Aquilo Sports CCT1500 System?

Aquilo Sports CCT1500 System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Aquilo Sports, LLC. The 510(k) number is K223164.

When did Aquilo Sports CCT1500 System receive FDA 510(k) clearance?

Aquilo Sports CCT1500 System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K223164.

Who is the listed applicant for Aquilo Sports CCT1500 System?

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

What is the FDA product code for Aquilo Sports CCT1500 System?

The FDA product code for Aquilo Sports CCT1500 System is IRP.

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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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