Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K212171 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Dongguan Kangweile Electronic Technology Co., Ltd.
4th Floor, Building D, Yizhong Science Park,
83 Jisha 2nd Road, Shuikou Village, Dalang Town
Dongguan 523770 CN
Other 510(k) Applications for this Company
|
Contact |
Zhixin Gao
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 |
07/12/2021 |
Decision Date |
11/01/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|