FDA 510(k) Application Details - DEN200055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200055
Device Name	GI Genius
Applicant	Cosmo Artificial Intelligence - AI, LTD Riverside II, Sir John RogersonÆs Quay Dublin D02 KV60 IE Other 510(k) Applications for this Company
Contact	Steven A. Kradjian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2020
Decision Date	04/09/2021
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review