Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K131227 |
Device Name |
System, Imaging, Pulsed Echo, Ultrasonic |
Applicant |
CARENOSO TECHNOLOGY CO., LTD.
4TH FL, NO. 11 BLDG INITIATING ZONE, INSTRUMENTS & METERS
INDUSTRY BASE, NEAR PORT INDUSTRY ZONE
DANDONG, LIAONING 118009 CN
Other 510(k) Applications for this Company
|
Contact |
ZHANG WENSHENG
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 |
04/30/2013 |
Decision Date |
07/12/2013 |
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 |
Y |
Expedited Review |
|