FDA 510(k) Application Details - K192662

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K192662
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	CapsoVision, Inc. 18805 Cox Avenue Suite 250 Saratoga, CA 95070 US Other 510(k) Applications for this Company
Contact	Azimun Jamal Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2019
Decision Date	02/14/2020
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