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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
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Bldg. 9-13 Baiwangxin High-Tec
Industrial Park
Shenzhen, Baimang, Xili Town,  CN 518108
Applicant Contact YANG ZHAOHUI
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/03/2012
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
Predetermined Change
Control Plan Authorized		 No
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