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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K013723
Device Name MODIFICATION TO: EUB-6500 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 Number892.1570
Classification Product Code
ITX  
Date Received11/09/2001
Decision Date 02/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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