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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 K912364
Device Name ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED
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 Number892.1570
Classification Product Code
ITX  
Date Received05/29/1991
Decision Date 08/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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