Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K151258 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
2/F WEST, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE
HI-TECH INDUSTRIAL PARK
NANSHAN DISTRICT, SHENZHEN, GUANGDONG 518057 CN
Other 510(k) Applications for this Company
|
Contact |
Xie Qiongyu
Other 510(k) Applications for this Contact |
Regulation Number |
870.1130
More FDA Info for this Regulation Number |
Classification Product Code |
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/12/2015 |
Decision Date |
02/18/2016 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|