FDA 510(k)

KIDNEY ASSIST-运输

K号: K211333 · 2022-01-20

决定日期2022-01-20

产品代码KDN

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决定实质等同

器械摘要

KIDNEY ASSIST-transport is the device name listed in this FDA 510(k) record. The listed applicant is Xvivo Perfusion AB. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K211333. 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 KIDNEY ASSIST-transport?

KIDNEY ASSIST-transport is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Xvivo Perfusion AB. The 510(k) number is K211333.

When did KIDNEY ASSIST-transport receive FDA 510(k) clearance?

KIDNEY ASSIST-transport received FDA 510(k) clearance on 2022-01-20, under 510(k) number K211333.

Who is the listed applicant for KIDNEY ASSIST-transport?

FDA 510(k)记录将Xvivo Perfusion AB列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for KIDNEY ASSIST-transport?

The FDA product code for KIDNEY ASSIST-transport is KDN.

列明Xvivo Perfusion AB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。

K261644Perfadex Plus K170826Perfadex Plus

官方来源

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