FUJIFILM Ultrasonic Endoscope

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 Ultrasonic Endoscope.

Pre-market Notification Details

Device IDK181763
510k NumberK181763
Device Name:FUJIFILM Ultrasonic Endoscope
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. 10 High Point Drive Wayne,  NJ  07470
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-03
Decision Date2018-07-27
Summary:summary

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