FUJIFILM EP-6000 Video Processor

Endoscopic Video Imaging System/component, Gastroenterology-urology

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Ep-6000 Video Processor.

Pre-market Notification Details

Device IDK192286
510k NumberK192286
Device Name:FUJIFILM EP-6000 Video Processor
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentCandace Alva
FujiFilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue Lexington,  MA  02421
Product CodeFET  
Subsequent Product CodeEOQ
Subsequent Product CodeNTN
Subsequent Product CodeNWB
Subsequent Product CodePEA
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-05-01

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.