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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 K192410
Device Name ZS3 and z.one pro Ultrasound Systems
Applicant
ShenZhen Mindray Bio-Medical Electronics Co., Ltd
Keji 12th Road South, High-tech Industrial Park,
Shenzhen,  CN 518057
Applicant Contact Jiang Haosen
Correspondent
ShenZhen Mindray Bio-Medical Electronics Co., Ltd
Keji 12th Road South, High-tech Industrial Park,
Shenzhen,  CN 518057
Correspondent Contact Jiang Haosen
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/04/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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