FDA 510(k)

DIASAFEplusUS (F00013010)

K号: K251851 · 2025-10-09

申请人Fresenius Medical Care Renal Therapies Group, LLC

决定日期2025-10-09

产品代码FIP

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

DIASAFEplusUS (F00013010) 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 2025-10-09 under 510(k) number K251851. 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 DIASAFEplusUS (F00013010)?

DIASAFEplusUS (F00013010) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K251851.

When did DIASAFEplusUS (F00013010) receive FDA 510(k) clearance?

DIASAFEplusUS (F00013010) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K251851.

Who is the listed applicant for DIASAFEplusUS (F00013010)?

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 DIASAFEplusUS (F00013010)?

The FDA product code for DIASAFEplusUS (F00013010) is FIP.

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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