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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K920664
Device Name DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
Applicant
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Applicant Contact GERALD MCMORROW
Correspondent
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Correspondent Contact GERALD MCMORROW
Regulation Number876.1725
Classification Product Code
FFX  
Date Received02/13/1992
Decision Date 12/23/1993
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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