Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K213070 |
Device Name |
System, Imaging, Pulsed Echo, Ultrasonic |
Applicant |
Meda Co., LTD
F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park,
Huayuan Industry Development Area
Tianjin 300384 CN
Other 510(k) Applications for this Company
|
Contact |
Linda 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 |
09/23/2021 |
Decision Date |
11/18/2021 |
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 |
|