Transcranial Doppler Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Shenzhen Delica Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Delica Medical Equipment Co., Ltd. with the FDA for Transcranial Doppler Ultrasound System.

Pre-market Notification Details

Device IDK213009
510k NumberK213009
Device Name:Transcranial Doppler Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Shenzhen Delica Medical Equipment Co., Ltd. 18F, Building B, High-tech Park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming Shenzhen,  CN 518107
ContactZhenhua Xiao
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeOQQ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2022-07-08


Device IdentifiersubmissionNumberSupplement
06970481940178 K213009 000
06970481940161 K213009 000

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