FDA 510(k) Application Details - K201096

Device Classification Name	Insufflator, Automatic Carbon-Dioxide For Endoscope   More FDA Info for this Device
510(K) Number	K201096
Device Name	Insufflator, Automatic Carbon-Dioxide For Endoscope
Applicant	Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Winkie Wong 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	04/24/2020
Decision Date	06/23/2020
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