FUJIFILM ENDOSCOPIC CO2 REGULATOR

Insufflator, Automatic Carbon-dioxide For Endoscope

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Endoscopic Co2 Regulator.

Pre-market Notification Details

Device IDK133976
510k NumberK133976
Device Name:FUJIFILM ENDOSCOPIC CO2 REGULATOR
ClassificationInsufflator, Automatic Carbon-dioxide For Endoscope
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne,  NJ  07470
ContactGina Walljasper
CorrespondentGina Walljasper
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne,  NJ  07470
Product CodeFCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-26
Decision Date2014-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410331608 K133976 000
04547410331592 K133976 000
04547410331585 K133976 000

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