FDA 510(k)

KabiHelp® Uno；KabiHelp® Advance plus

K号: K251139 · 2026-01-09

决定日期2026-01-09

产品代码KPE

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决定实质等同

器械摘要

KabiHelp® Uno; KabiHelp® Advance plus is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K251139. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KabiHelp® Uno; KabiHelp® Advance plus?

KabiHelp® Uno; KabiHelp® Advance plus is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Fresenius Kabi AG. The 510(k) number is K251139.

When did KabiHelp® Uno; KabiHelp® Advance plus receive FDA 510(k) clearance?

KabiHelp® Uno; KabiHelp® Advance plus received FDA 510(k) clearance on 2026-01-09, under 510(k) number K251139.

Who is the listed applicant for KabiHelp® Uno; KabiHelp® Advance plus?

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

What is the FDA product code for KabiHelp® Uno; KabiHelp® Advance plus?

The FDA product code for KabiHelp® Uno; KabiHelp® Advance plus is KPE.

列明Fresenius Kabi AG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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官方来源

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