FDA 510(k)

NovaLine 血液透析管路套装

K号: K201866 · 2021-03-10

申请人Bain Medical Equipment (Guangzhou) Co., Ltd.

决定日期2021-03-10

产品代码FJK

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决定实质等同

器械摘要

NovaLine Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K201866. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NovaLine Tubing Sets for Hemodialysis?

NovaLine Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K201866.

When did NovaLine Tubing Sets for Hemodialysis receive FDA 510(k) clearance?

NovaLine Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2021-03-10, under 510(k) number K201866.

Who is the listed applicant for NovaLine Tubing Sets for Hemodialysis?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaLine Tubing Sets for Hemodialysis?

The FDA product code for NovaLine Tubing Sets for Hemodialysis is FJK.

列明Bain Medical Equipment (Guangzhou) Co., Ltd.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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