FDA 510(k) Application Details - K180171

Device Classification Name	System, Imaging, Esophageal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K180171
Device Name	System, Imaging, Esophageal, Wireless, Capsule
Applicant	Given Imaging Ltd. 2 Hacarmet St. New Industrial Park POB 258 Yoqneam 20692 IL Other 510(k) Applications for this Company
Contact	Hilla Debby Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2018
Decision Date	03/08/2018
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