FDA 510(k) Application Details - K101273

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K101273
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	CONTEC MEDICAL SYSTEM CO., LTD. SUITE 5D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD(S) SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2010
Decision Date	09/30/2011
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