FDA 510(k) Application Details - K140149

Device Classification Name	More FDA Info for this Device
510(K) Number	K140149
Device Name	EPX-4440HD DIGITAL VIDEO PROCESSOR
Applicant	FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 10 HIGH POINT DR WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	MARY K MOORE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2014
Decision Date	08/22/2014
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