Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K173595 |
Device Name |
System, Imaging, Pulsed Echo, Ultrasonic |
Applicant |
Wuxi Hisky Medical Technologies Co., Ltd.
Room B401, 530 Plaza, University Science Park,
Taihu International Science & Technology Park
Wuxi 214135 CN
Other 510(k) Applications for this Company
|
Contact |
Jinhua Shao
Other 510(k) Applications for this Contact |
Regulation Number |
892.1560
More FDA Info for this Regulation Number |
Classification Product Code |
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/21/2017 |
Decision Date |
06/22/2018 |
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 |
|