FDA 510(k) Application Details - K163069

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K163069
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji 182-8507 JP Other 510(k) Applications for this Company
Contact	Toshiyuki Nakajima 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	11/02/2016
Decision Date	01/19/2017
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