Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K200450 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Alpinion Medical Systems Co., Ltd.
5FL, I dong, 77, heungan-daero 81 beon-gil dongan-gu
Anyang-si 14117 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 |
02/24/2020 |
Decision Date |
07/10/2020 |
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 |
|