FUJIFILM Ultrasonic Endoscope

Bronchoscope (flexible Or 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 IDK182825
510k NumberK182825
Device Name:FUJIFILM Ultrasonic Endoscope
ClassificationBronchoscope (flexible Or 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 CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-04
Decision Date2019-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410330182 K182825 000

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