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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 Echo, Ultrasonic
510(k) Number K862164
Device Name EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
Applicant
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Applicant Contact MEDICAL SYST
Correspondent
Hitachi Medical Corp. of America
50 Prospect Ave.
Tarrytown,  NY  10591
Correspondent Contact MEDICAL SYST
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/06/1986
Decision Date 11/04/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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