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FDA 510(k)

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

K-Number: K233964 · 2024-01-12

Decision Date2024-01-12
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) is a medical device manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. It received FDA 510(k) clearance on 2024-01-12 under approval number K233964. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Cosmo Artificial Intelligence - Ai, Ltd.. The 510(k) number is K233964.

When was GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) approved by the FDA?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) received FDA 510(k) clearance on 2024-01-12, under approval number K233964.

What company makes GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)?

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) is manufactured by Cosmo Artificial Intelligence - Ai, Ltd..

What is the FDA product code for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)?

The FDA product code for GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) is QNP.

Other Devices by Cosmo Artificial Intelligence - Ai, Ltd.

Related Devices (Code: QNP)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.