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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 K120699
Device Name DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
mindray building, keji 12th rd
south, hi-tech industrial park
nanshan,shenzhen, p.r. china, 
Contact wu zicui
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/07/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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