GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)— 510(k) K241887

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K241887 for GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US), Substantially Equivalent on 2024-07-25. Applicant: Cosmo Artificial Intelligence - Ai, Ltd..

Clearance details

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2024-06-28
Decision date: 2024-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

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