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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 K970508
Device Name ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502 -1328
Applicant Contact YASUHARU ISHII
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502 -1328
Correspondent Contact YASUHARU ISHII
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/10/1997
Decision Date 08/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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