Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K161845 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Shenzhen Pango Electronic Co.,Ltd.
No.25, 1st Industrial Park, Fenghuang Road
Xikeng, Henggang,Longgang District
Shenzhen 518115 CN
Other 510(k) Applications for this Company
|
Contact |
Xiaoyun Yang
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 |
07/05/2016 |
Decision Date |
07/31/2017 |
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 |
|