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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 Road South, Hi-tech Industrial Park
Shenzhen,  CN 518057
Applicant Contact Hao Yixuan
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Keji 12th Road South, 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
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