FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2

Gastroscope And Accessories, Flexible/rigid

FUJINON, INC.

The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon/fujifilm Ultrasonic Endoscope Eg-530ur2 And Eg-530ut2.

Pre-market Notification Details

Device IDK120446
510k NumberK120446
Device Name:FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant FUJINON, INC. 10 HIGH POINT DR. Wayne,  NJ  07470
ContactMark Job
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-02-14
Decision Date2012-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410339437 K120446 000
04547410339420 K120446 000
04547410331578 K120446 000
04547410331561 K120446 000
24547410138515 K120446 000

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