FDA 510(k) Application Details - DEN180055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180055
Device Name	CARPEDIEM System
Applicant	Bellco srl (now part of Medtronic, Inc) Via Camurana 1 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Matteo Chiappini Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2018
Decision Date	04/29/2020
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