FUJIFILM Duodenoscope Model ED-580XT

Duodenoscope And Accessories, Flexible/rigid

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Duodenoscope Model Ed-580xt.

Pre-market Notification Details

Device IDK191747
510k NumberK191747
Device Name:FUJIFILM Duodenoscope Model ED-580XT
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentKamila Sak
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-09-27
Summary:summary

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