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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 K173801
Device Name Transcranial Doppler Ultrasound System
Applicant
Shenzhen Delica Medical Equipment Co., Ltd.
6c, Block 10, The Second Industrial Zone
Guanlong, Nanshan District
Shenzhen,  CN 518055
Applicant Contact Zhenhua Xiao
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   OQQ  
Date Received12/14/2017
Decision Date 07/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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