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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 K212265
Device Name TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S., Hi-Tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Hao Yixuan
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Keji 12th Rd. S., Hi-Tech Industrial Park
Shenzhen,  CN 518057
Correspondent Contact Hao Yixuan
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/20/2021
Decision Date 11/16/2021
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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