FDA 510(k) Application Details - DEN220073

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220073
Device Name	Revi System
Applicant	BlueWind Medical Ltd. 6 Maskit Street Herzliya 4614002 IL Other 510(k) Applications for this Company
Contact	Roni Diaz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2022
Decision Date	08/16/2023
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