FDA 510(k)

Belzer MPS®（UW 机灌注溶液）（BMPS-001）

K号: K243840 · 2025-03-26

决定日期2025-03-26

产品代码KDN

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

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K243840. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)?

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Bridge TO Life. The 510(k) number is K243840.

When did Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) receive FDA 510(k) clearance?

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K243840.

Who is the listed applicant for Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)?

The FDA 510(k) record lists Bridge TO Life as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)?

The FDA product code for Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is KDN.

列明Bridge TO Life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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