Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K191894 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
ShenZhen ZhengKang Technology Co., Ltd.
3/F, Building A, No. 3 FuXing Yi Lane, HeHua Community,
PingHu Street
ShenZhen City 518100 CN
Other 510(k) Applications for this Company
|
Contact |
Huayong 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 |
07/15/2019 |
Decision Date |
02/21/2020 |
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 |
|