EVIS EXERA III VIDEO SYSTEM


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K112680
Device Name EVIS EXERA III VIDEO SYSTEM
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Applicant Contact stacy abbatiello kluesner
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley, 
PA 
18034 -0610

Correspodent Contact stacy abbatiello kluesner
Regulation Number 876.1500
Classification Product Code
FDF  
Date Received 09/14/2011
Decision Date 02/16/2012
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