| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
| 510(K) Number |
K182018 |
| Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
| Applicant |
Shenzhen Kingyield Technology Co., Ltd.
Section C2, Fuhai Industrial Zone, Fuyong Town,
Baoan District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
|
| Contact |
Dacheng Gong
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 |
07/27/2018 |
| Decision Date |
10/06/2018 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CV - Cardiovascular |
| Review Advisory Committee |
CV - Cardiovascular |
| Statement / Summary / Purged Status |
Summary |
| Type |
Special |
| Reviewed By Third Party |
N |
| Expedited Review |
|