FDA 510(k)

肠内过渡适配器

K号: K220165 · 2022-10-21

决定日期2022-10-21

产品代码PIO

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决定实质等同

器械摘要

Enteral Transition Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is GBUK Group, Ltd.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K220165. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Enteral Transition Adaptor?

Enteral Transition Adaptor is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is GBUK Group, Ltd.. The 510(k) number is K220165.

When did Enteral Transition Adaptor receive FDA 510(k) clearance?

Enteral Transition Adaptor received FDA 510(k) clearance on 2022-10-21, under 510(k) number K220165.

Who is the listed applicant for Enteral Transition Adaptor?

The FDA 510(k) record lists GBUK Group, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enteral Transition Adaptor?

The FDA product code for Enteral Transition Adaptor is PIO.

列明GBUK Group, 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。

K203633肠内延长管

官方来源

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