GI Genius System 100 and GI Genius System 200— 510(k) K231143

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K231143 for GI Genius System 100 and GI Genius System 200, Substantially Equivalent on 2023-05-19. Applicant: Cosmo Artificial Intelligence - Ai, Ltd..

Clearance details

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-21
Decision date: 2023-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

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