FDA 510(k) Application Details - K123047

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K123047
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	BRACCO DIAGNOSTIC, INC. 107 COLLEGE ROAD PRINCETON, NJ 08540 US Other 510(k) Applications for this Company
Contact	TRACEY ALEXANDER Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2012
Decision Date	08/06/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review