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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 K121010
Device Name M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
bldg. 9-13 baiwangxin high-tec
industrial park
shenzhen,  CH 518108
Original Contact yang zhaohui
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/03/2012
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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