GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)— 510(k) K233964

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K233964 for GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US), Substantially Equivalent on 2024-01-12. Applicant: Cosmo Artificial Intelligence - Ai, Ltd..

Clearance details

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-15
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

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