Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K193386 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Shenzhen Changkun Technology Co., Ltd.
801, 3 Floor, 4 Floor, 5 Floor, 6 Floor, 7 Floor
B building, NO. 69, Zhenbi Road
Shenzhen 518118 CN
Other 510(k) Applications for this Company
|
Contact |
Steve Li
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 |
12/06/2019 |
Decision Date |
01/27/2021 |
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 |
|