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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 echo, ultrasonic
510(K) Number K113632
Models DP-5, DP-7
Device Name DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Applicant
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
55 northern blvd.
suite 200
new york,  NY  11021
Contact susan d goldstein
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received12/05/2011
Decision Date 01/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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