Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K191055 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Samsung Medison Co., Ltd.
3366, Hanseo-ro, Nam-myeon,
Hongcheon-gun 25108 KR
Other 510(k) Applications for this Company
|
Contact |
Scully Kim
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 |
04/19/2019 |
Decision Date |
06/12/2019 |
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 |
N |
Expedited Review |
|