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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 K111435
Device Name DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/23/2011
Decision Date 07/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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