Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K181617 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Alpinion Medical Systems Co., Ltd.
1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu
Seoul 08393 KR
Other 510(k) Applications for this Company
|
Contact |
Boyeon CHO
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 |
06/19/2018 |
Decision Date |
10/11/2018 |
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 |
|