FUJIFILM Endoscope Model EG-740N

Gastroscope 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 Eg-740n.

Pre-market Notification Details

Device IDK182836
510k NumberK182836
Device Name:FUJIFILM Endoscope Model EG-740N
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave Stamford,  CT  06902
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-09
Decision Date2019-04-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410377248 K182836 000

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