FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H

Bronchoscope (flexible Or Rigid)

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 Fujinon/fujifilm Eb-530 Series Bronchoscopes (eb-530s, Eb-530t And Eb-530h.

Pre-market Notification Details

Device IDK122535
510k NumberK122535
Device Name:FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
ClassificationBronchoscope (flexible Or Rigid)
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne,  NJ  07470
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-08-20
Decision Date2012-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410333312 K122535 000
04547410330168 K122535 000
04547410330151 K122535 000
24547410132780 K122535 000
14547410093299 K122535 000
04547410093285 K122535 000
04547410079074 K122535 000
04547410079067 K122535 000
04547410079036 K122535 000

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