Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K131558 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
SHENZHEN PANGO ELECTRONIC CO., LTD
XIKENG VILLAGE, HENGGANG TOWN,
LONGGANG DISTRICT
ZHENZHEN, GUANGDONG 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 |
05/30/2013 |
Decision Date |
08/30/2013 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
Y |
Expedited Review |
|