FUJIFILM Endoscopic CO2 Regulator GW-100

Insufflator, Automatic Carbon-dioxide For Endoscope

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Endoscopic Co2 Regulator Gw-100.

Pre-market Notification Details

Device IDK180711
510k NumberK180711
Device Name:FUJIFILM Endoscopic CO2 Regulator GW-100
ClassificationInsufflator, Automatic Carbon-dioxide For Endoscope
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 40 Boroline Road Allendale,  NJ  07401
Product CodeFCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-19
Decision Date2018-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410366051 K180711 000
04547410366037 K180711 000

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