Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K230409 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park, No.2
Guiyuan Rd.,Guixiang Community,Guanlan St.,Longhua District
Shenzhen 518100 CN
Other 510(k) Applications for this Company
|
Contact |
Haiyu Zhang
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 |
02/15/2023 |
Decision Date |
08/25/2023 |
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 |
|