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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 K190228
Device Name Transcranial Doppler Ultrasound System
Applicant
Shenzhen Delica Medical Equipment Co., Ltd.
F, Block 10, The Second Industrial Zone
Guanlong, Nanshan District
Shenzhen,  CN 51855
Applicant Contact Yolanda Lan
Correspondent
Shenzhen Delica Medical Equipment Co., Ltd.
F, Block 10, The Second Industrial Zone
Guanlong, Nanshan District
Shenzhen,  CN 51855
Correspondent Contact Yolanda Lan
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DXN   DXQ   ITX   OQQ  
Date Received02/05/2019
Decision Date 06/13/2019
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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