FDA 510(k)

AQUAbase nX

K号: K223479 · 2023-08-16

决定日期2023-08-16

产品代码FIP

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决定实质等同

器械摘要

AQUAbase nX is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223479. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AQUAbase nX?

AQUAbase nX is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K223479.

When did AQUAbase nX receive FDA 510(k) clearance?

AQUAbase nX received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223479.

Who is the listed applicant for AQUAbase nX?

FDA 510(k)记录中列出了B.Braun Medical, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for AQUAbase nX?

The FDA product code for AQUAbase nX is FIP.

列明B.Braun Medical, Inc.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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