FDA 510(k)

GI Genius

K号: K211951 · 2021-07-23

申请人Cosmo Artificial Intelligence - Ai, Ltd.

决定日期2021-07-23

产品代码QNP

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决定实质等同

器械摘要

GI Genius is the device name listed in this FDA 510(k) record. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211951. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GI Genius?

GI Genius is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K211951.

When did GI Genius receive FDA 510(k) clearance?

GI Genius received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211951.

Who is the listed applicant for GI Genius?

The FDA 510(k) record lists Cosmo Artificial Intelligence - Ai, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GI Genius?

The FDA product code for GI Genius is QNP.

列明Cosmo Artificial Intelligence - Ai, 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。

K261369GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ US (CPRO403S-US)K241887GI Genius™ 模块 100 (GGM100.US)；GI Genius™ 模块 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)；GI Genius™ 模块 300 (GGM300-US)；ColonPRO™ 4.0 (CPRO40S-US)K233964GI Genius™ 模块 100 (GGM100.US)；GI Genius™ 模块 200 (GGM200.US)；ColonPRO™ 4.0 (CPRO40.US)K231143GI Genius 系统 100 和 GI Genius 系统 200

官方来源

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