Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K192609 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Globalcare Medical Technology Co., Ltd
No.7 Factory, European Industrial Park,
No. 39 Mid Industrial Main Road
Xiaolan Town, Zhongshan City 528415 CN
Other 510(k) Applications for this Company
|
Contact |
Janice Deng
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 |
09/20/2019 |
Decision Date |
04/21/2020 |
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 |
|