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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 K200411
Device Name Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S., Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Shi Jufang
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S., Hi-Tech Industrial Park
Shenzhen,  CN 518057
Correspondent Contact Shi Jufang
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/19/2020
Decision Date 04/08/2020
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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