FDA 510(k) Application Details - K162332

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K162332
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	NEXCORE TECHNOLOGY, LLC P.O. Box 903 Winchester, MA 01890 US Other 510(k) Applications for this Company
Contact	Julie Broderick 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	08/19/2016
Decision Date	09/29/2016
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	Y
Expedited Review