FDA 510(k) Application Details - K190985

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K190985
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	BAROnova, Inc. 1551 Industrial Road San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Lian Cunningham 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	04/15/2019
Decision Date	05/14/2019
Decision	SESK - SUBST EQUIV - KIT
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