Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device |
510(K) Number |
K101692 |
Device Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
Applicant |
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI 200030 CN
Other 510(k) Applications for this Company
|
Contact |
Diana Hong
Other 510(k) Applications for this Contact |
Regulation Number |
870.1025
More FDA Info for this Regulation Number |
Classification Product Code |
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/16/2010 |
Decision Date |
06/28/2011 |
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 |
|