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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 K910268
Device Name TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T
Applicant
Hitachi Medical Corp.
50 Prospect Ave.
Tarrytown,  NY  10591
Applicant Contact TAKIGUCHI
Correspondent
Hitachi Medical Corp.
50 Prospect Ave.
Tarrytown,  NY  10591
Correspondent Contact TAKIGUCHI
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/15/1991
Decision Date 04/15/1991
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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