Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K192254 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Qisda Corporation
No.157, Shanying Rd, Shan-Ting Li, Gueishan Dist,
Taoyuan TW
Other 510(k) Applications for this Company
|
Contact |
Johnson Sheu
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 |
08/20/2019 |
Decision Date |
09/18/2019 |
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 |
Y |
Expedited Review |
|