FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US

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 Ultrasonic Endoscope Eb-530us.

Pre-market Notification Details

Device IDK121035
510k NumberK121035
Device Name:FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
ClassificationBronchoscope (flexible Or Rigid)
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne,  NJ  07470
ContactGina Walljasper
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 Received2012-04-05
Decision Date2012-06-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410333435 K121035 000
04547410330182 K121035 000
04547410111408 K121035 000
04547410111392 K121035 000
04547410104349 K121035 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.