GI Genius— 510(k) K211951

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K211951 for GI Genius, Substantially Equivalent on 2021-07-23. Applicant: Cosmo Artificial Intelligence - Ai, Ltd..

Clearance details

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-23
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

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