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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 Rd. S., High-Tech Industrial Park,
Shenzhen,  CN 518057
Applicant Contact Jiang Haosen
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S., 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
Predetermined Change
Control Plan Authorized		 No
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