K231143

Substantially Equivalent

GI Genius System 100 and GI Genius System 200

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