FDA 510(k)

multiFlux 130（F00013123）；multiFlux 160（F00013124）

K号: K252459 · 2026-02-10

申请人Fresenius Medical Care Renal Therapies Group, LLC

决定日期2026-02-10

产品代码KDI

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

multiFlux 130 (F00013123); multiFlux 160 (F00013124) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-02-10 under 510(k) number K252459. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

multiFlux 130 (F00013123); multiFlux 160 (F00013124) is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K252459.

When did multiFlux 130 (F00013123); multiFlux 160 (F00013124) receive FDA 510(k) clearance?

multiFlux 130 (F00013123); multiFlux 160 (F00013124) received FDA 510(k) clearance on 2026-02-10, under 510(k) number K252459.

Who is the listed applicant for multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

FDA 510(k)记录中列出Fresenius Medical Care Renal Therapies Group, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

The FDA product code for multiFlux 130 (F00013123); multiFlux 160 (F00013124) is KDI.

列明Fresenius Medical Care Renal Therapies Group, LLC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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