K241887

Substantially Equivalent

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)

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.