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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, Obstetric
510(k) Number K900966
Device Name EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
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 Number884.2960
Classification Product Code
HGL  
Date Received03/01/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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