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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 K131780
Device Name EVIS EXERA III VIDEO SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact DAPHNEY GERMAIN-KOLAWOLE
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   NWB  
Date Received06/17/2013
Decision Date 08/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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