Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K163427 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
SONOSCAPE MEDICAL CORP.
4/f, 5/f, 8/f, 9/f & 10/f, yizhe building
yuquan road, nanshan
Shenzhen 518051 CN
Other 510(k) Applications for this Company
|
Contact |
Toki Wu
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 |
12/06/2016 |
Decision Date |
01/03/2017 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|