Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K170374 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
CHISON Medical Imaging Co., Ltd.
NO.228, ChangJiang East Road,Block 51 and 53,
Phase 5 Industrial Park ShouFa
Wuxi 214142 CN
Other 510(k) Applications for this Company
|
Contact |
Qifei Liu
Other 510(k) Applications for this Contact |
Regulation Number |
892.1550
More FDA Info for this Regulation Number |
Classification Product Code |
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/07/2017 |
Decision Date |
06/06/2017 |
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 |
|