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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 K172970
Device Name M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S. High-Tech Industrial
Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Yang Zhaohui
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S. High-Tech Industrial
Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yang Zhaohui
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/26/2017
Decision Date 10/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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