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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 Doppler, Ultrasonic
510(k) Number K003515
Device Name ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
Applicant
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact MASAAKI SHIBATA
Correspondent
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact MASAAKI SHIBATA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/14/2000
Decision Date 02/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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