Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K142088 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
BLOCK 6 AND 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN,
LONG GANG DISTRICT, SHENZHEN,
GUANG DONG CN
Other 510(k) Applications for this Company
|
Contact |
PATRICK CHOW
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 |
08/01/2014 |
Decision Date |
10/31/2014 |
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 |
N |
Expedited Review |
|