FDA 510(k) Application Details - K241887

Device Classification Name	More FDA Info for this Device
510(K) Number	K241887
Device Name	GI GeniusÖ Module 100 (GGM100.US); GI GeniusÖ Module 200 (GGM200.US); ColonPROÖ 4.0 (CPRO40.US); GI GeniusÖ Module 300 (GGM300-US); ColonPROÖ 4.0 (CPRO40S-US)
Applicant	Cosmo Artificial Intelligence - AI Ltd Riverside II Sir John Rogerson's Quay Dublin D02 KV60 IE Other 510(k) Applications for this Company
Contact	Ngo Dinh Nhan 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	06/28/2024
Decision Date	07/25/2024
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