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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 K934623
Device Name ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
Applicant
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Applicant Contact RANDY A WILSON
Correspondent
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact RANDY A WILSON
Regulation Number876.1500
Classification Product Code
FET  
Date Received09/27/1993
Decision Date 12/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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