Fujifilm Video Colonoscope Model EC-600WL V2

Colonoscope And Accessories, Flexible/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 Video Colonoscope Model Ec-600wl V2.

Pre-market Notification Details

Device IDK160196
510k NumberK160196
Device Name:Fujifilm Video Colonoscope Model EC-600WL V2
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne,  NJ  07470
ContactShraddha More
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 Thirteenth St. NW Washington,  DC  20004
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2016-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410337396 K160196 000

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