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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K944254
FOIA Releasable 510(k) K944254
Device Name OKTAS STEREO VIEWING SYSTEM
Applicant
OKTAS
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Applicant Contact KEN HORI
Correspondent
OKTAS
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Correspondent Contact KEN HORI
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Code
GCJ  
Date Received08/31/1994
Decision Date 11/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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