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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K902692
Device Name DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
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 Number876.1620
Classification Product Code
FAP  
Date Received06/19/1990
Decision Date 09/13/1990
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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