FDA 510(k) Application Details - K132192

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K132192
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	BRACCO DIAGNOSTIC, INC. 259 PROSPECT PLAINS ROAD BUILDING H MONROE TOWNSHIP, NJ 08831 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	07/15/2013
Decision Date	02/14/2014
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