FDA 510(k) Application Details - K180414

Device Classification Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K180414
Device Name	Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant	FUJIFILM New Development U.S.A., Inc. 318 Bear Hill Road Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Stephen Mariano Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FET Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2018
Decision Date	05/24/2018
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