FUJIFILM Endoscope Model EC-760Z-V/L

Colonoscope And Accessories, Flexible/rigid

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscope Model Ec-760z-v/l.

Pre-market Notification Details

Device IDK192664
501k NumberK192664
Device Name:FUJIFILM Endoscope Model EC-760Z-V/L
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentTommy San
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2019-11-20

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