| Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
| 510(K) Number |
K241979 |
| Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant |
Beijing Konted Medical Technology Co.,Ltd
Room 111, Building 3, No. 27,Yongwang Road, Daxing
Biological Pharmaceutial Industry Base Daxing District
Beijing 102629 CN
Other 510(k) Applications for this Company
|
| Contact |
Deyi Zhu
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 |
07/05/2024 |
| Decision Date |
08/22/2024 |
| 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 |
|