Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K152318 |
Device Name |
System, Imaging, Pulsed Echo, Ultrasonic |
Applicant |
MEDA CO.,LTD
F2C,F3D,F4C,F5,F6C,BLDG C2,Xinmao Science Skill Park
Huayuan Ind. Area
TIANJIN 300384 CN
Other 510(k) Applications for this Company
|
Contact |
Yusheng ZHANG
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 |
08/17/2015 |
Decision Date |
11/17/2015 |
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 |
|