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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K870878
Device Name EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
Applicant
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Applicant Contact UEHARA
Correspondent
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Correspondent Contact UEHARA
Regulation Number870.2330
Classification Product Code
DXK  
Date Received03/04/1987
Decision Date 04/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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