Device Classification Name |
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device |
510(K) Number |
K172965 |
Device Name |
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) |
Applicant |
Visiomed Technology Co.,Ltd
2 Floor of No.1 Building,
Jia An Technological Industial Park, 67 District,
Bao An, Shenzhen, 518000 CN
Other 510(k) Applications for this Company
|
Contact |
Chen XiaoFeng
Other 510(k) Applications for this Contact |
Regulation Number |
870.2300
More FDA Info for this Regulation Number |
Classification Product Code |
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/26/2017 |
Decision Date |
12/17/2018 |
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 |
|