FDA 510(k) Application Details - K111648

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K111648
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	BRACCO DIAGNOSTIC, INC. 532 BROADHOLLOW ROAD SUITE 126 MELVILLE, NY 11747 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	06/13/2011
Decision Date	11/03/2011
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