FDA 510(k)

BEL-GEN 冷藏解决方案

K号: K221387 · 2022-06-14

决定日期2022-06-14

产品代码KDL

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决定实质等同

器械摘要

BEL-GEN Cold Storage Solution is the device name listed in this FDA 510(k) record. The listed applicant is Institut Georges Lopez. It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K221387. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BEL-GEN Cold Storage Solution?

BEL-GEN Cold Storage Solution is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is Institut Georges Lopez. The 510(k) number is K221387.

When did BEL-GEN Cold Storage Solution receive FDA 510(k) clearance?

BEL-GEN Cold Storage Solution received FDA 510(k) clearance on 2022-06-14, under 510(k) number K221387.

Who is the listed applicant for BEL-GEN Cold Storage Solution?

The FDA 510(k) record lists Institut Georges Lopez as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEL-GEN Cold Storage Solution?

The FDA product code for BEL-GEN Cold Storage Solution is KDL.

列明Institut Georges Lopez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。

K221386PERF-GEN 脉冲灌注溶液 K211224RM4控制单元

官方来源

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