FDA 510(k)

Belzer UW® 冷藏溶液（BTLBUW-001）

K号: K243384 · 2025-03-31

决定日期2025-03-31

产品代码KDN

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决定实质等同

器械摘要

Belzer UW® Cold Storage Solution (BTLBUW-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 2025-03-31 under 510(k) number K243384. 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 UW® Cold Storage Solution (BTLBUW-001)?

Belzer UW® Cold Storage Solution (BTLBUW-001) is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Bridge TO Life. The 510(k) number is K243384.

When did Belzer UW® Cold Storage Solution (BTLBUW-001) receive FDA 510(k) clearance?

Belzer UW® Cold Storage Solution (BTLBUW-001) received FDA 510(k) clearance on 2025-03-31, under 510(k) number K243384.

Who is the listed applicant for Belzer UW® Cold Storage Solution (BTLBUW-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 UW® Cold Storage Solution (BTLBUW-001)?

The FDA product code for Belzer UW® Cold Storage Solution (BTLBUW-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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