Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K161708 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD
2/F, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE,
HI-TECH INDUSTRIAL PARK
NANSHAN DISTRICT, SHENZHEN 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 |
06/21/2016 |
Decision Date |
11/22/2016 |
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 |
|