Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K210591 |
Device Name |
System, Imaging, Pulsed Echo, Ultrasonic |
Applicant |
Mianyang Meike Electronic Equipment Co., Ltd.
No., 63, Yinping Road, Longmen Town, Fucheng District,
Mianyang. Sichuan
Mianyang 621000 CN
Other 510(k) Applications for this Company
|
Contact |
Wenjun Zhao
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 |
03/01/2021 |
Decision Date |
06/09/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|