FUJIFILM Video Bronchoscopes

Bronchoscope (flexible Or Rigid)

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Video Bronchoscopes.

Pre-market Notification Details

Device IDK182253
510k NumberK182253
Device Name:FUJIFILM Video Bronchoscopes
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. 10 High Point Drive Wayne,  NJ  07470
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-20
Decision Date2019-04-04

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