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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 K113613
Device Name DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
Applicant
Shantou Institute of Ultrasonic Instuments
77 Jinsha Rd.
Shantou,  CN 515041
Applicant Contact FLOWER CAI
Correspondent
Shantou Institute of Ultrasonic Instuments
77 Jinsha Rd.
Shantou,  CN 515041
Correspondent Contact FLOWER CAI
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/06/2011
Decision Date 06/15/2012
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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