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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 K103144
Device Name DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
Applicant
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Cir.
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Shantou Institute of Ultrasonic Instruments (Siui
7263 Cronin Cir.
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/25/2010
Decision Date 01/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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