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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 K011252
Device Name EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
Applicant
Hitachi Medical Corp.
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact WALTER WEYBURNE
Correspondent
Hitachi Medical Corp.
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact WALTER WEYBURNE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/24/2001
Decision Date 05/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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