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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 K171034
Device Name M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S.
Hi-Tech Industrial Park, Nanshan
Shenzhen,  CN
Applicant Contact Ma Chao
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S.
Hi-Tech Industrial Park, Nanshan
Shenzhen,  CN
Correspondent Contact Ma Chao
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/06/2017
Decision Date 07/10/2017
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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