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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 Doppler, Ultrasonic
510(k) Number K013722
Device Name MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
Applicant
Hitachi Medical Corp.
660 White Plains Rd.
Tarrytown,  NY  10591 -5107
Applicant Contact WALTER WEYBURNE
Correspondent
Hitachi Medical Corp.
660 White Plains Rd.
Tarrytown,  NY  10591 -5107
Correspondent Contact WALTER WEYBURNE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received11/09/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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