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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 K901657
Device Name ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
Applicant
HITACHI MEDICAL CORP. OF AMERICA
50 PROSPECT AVE.
TARRYTOWN,  NY  10591
Applicant Contact TAKIGUCHI
Correspondent
HITACHI MEDICAL CORP. OF AMERICA
50 PROSPECT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact TAKIGUCHI
Regulation Number870.2330
Classification Product Code
DXK  
Date Received04/10/1990
Decision Date 09/04/1990
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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