Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K180461 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Shenzhen Wisonic Medical Technology Co., Ltd.
1st and 5th Floor,No. 6 Building Pingshan Tech Park,
Taoyuan Street, Nanshan
Shenzhen 518055 CN
Other 510(k) Applications for this Company
|
Contact |
Jiang Xiaosan
Other 510(k) Applications for this Contact |
Regulation Number |
892.1550
More FDA Info for this Regulation Number |
Classification Product Code |
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/20/2018 |
Decision Date |
05/09/2018 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|