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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 K945795
Device Name EUB-555A+
Applicant
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact CHARLES F HOTTINGER
Correspondent
Hitachi Medical Corp. of America
660 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact CHARLES F HOTTINGER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/25/1994
Decision Date 10/27/1995
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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