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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K030763
Device Name DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
Applicant
Diagnostic Ultrasound Corp.
21222 30th Dr. SE, Suite 120
Bothell,  WA  98021
Applicant Contact NANCY GERTLAR
Correspondent
Tuv Rheinland of North America, Inc.
1279 Quarry Lane, Suite A
Pleasanton,  CA  94566
Correspondent Contact HEINZ J STENEBERG
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/11/2003
Decision Date 03/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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