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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
Original Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
mindray building, keji 12th rd
south, hi-tech industrial park
nanshan,shenzhen, p.r. china,  CN 518057
Original 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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