FDA 510(k) Application Details - K231143

Device Classification Name	More FDA Info for this Device
510(K) Number	K231143
Device Name	GI Genius System 100 and GI Genius System 200
Applicant	Cosmo Artificial Intelligence - AI Ltd Riverside II, Sir John RogersonÆs Quay Dublin D02 KV60 IE Other 510(k) Applications for this Company
Contact	Nhan Ngo Dinh 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	04/21/2023
Decision Date	05/19/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review