Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device |
510(K) Number |
K211127 |
Device Name |
System, Measurement, Blood-Pressure, Non-Invasive |
Applicant |
Health & Life Co., Ltd
9F, No. 186, Jian Yi Road, Zhonghe District
New Taipei City 23553 TW
Other 510(k) Applications for this Company
|
Contact |
Peggy Su
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 |
04/16/2021 |
Decision Date |
09/08/2021 |
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 |
|