Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K162267 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
MINDRAY BUILDING, KEJI 12TH RD S, HI-TECH INDUSTRIAL PARK,
NANSHAN
SHENZHEN 518057 CN
Other 510(k) Applications for this Company
|
Contact |
Zhai Pei
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 |
08/11/2016 |
Decision Date |
09/06/2016 |
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 |
|