FUJIFILM Bronchoscope Model EB-530P

Bronchoscope (flexible Or Rigid)

FUJIFILM Medical Systems U.S.A., Inc.

The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Bronchoscope Model Eb-530p.

Pre-market Notification Details

Device IDK171291
510k NumberK171291
Device Name:FUJIFILM Bronchoscope Model EB-530P
ClassificationBronchoscope (flexible Or Rigid)
Applicant FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne,  NJ  07470
ContactShraddha S. More
CorrespondentShraddha S. More
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 Received2017-05-02
Decision Date2018-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14547410343202 K171291 000

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