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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 K994026
Device Name EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
Applicant
Hitachi Medical Corp. of America
19030 Portos Dr.
Saratoga,  CA  95070
Applicant Contact CHARLES F HOTTINGER
Correspondent
Hitachi Medical Corp. of America
19030 Portos Dr.
Saratoga,  CA  95070
Correspondent Contact CHARLES F HOTTINGER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received11/26/1999
Decision Date 03/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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