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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K143732
Device Name FUJIFILM Endoscope Models EC-600HL and EC-600LS
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Applicant Contact Mary Moore
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Correspondent Contact Mary Moore
Regulation Number876.1500
Classification Product Code
FDF  
Date Received12/29/2014
Decision Date 07/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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