Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K211321 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Guangzhou Sonostar Technologies Co., Ltd.
504#, C Building,#27 Yayingshi Road, Science Town
Guangzhou 510665 CN
Other 510(k) Applications for this Company
|
Contact |
Weizhong Cai
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 |
04/30/2021 |
Decision Date |
10/13/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Abbreviated |
Reviewed By Third Party |
N |
Expedited Review |
|