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 Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/14/2017 |
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
|
|
|