FDA 510(k) Application Details - K131897

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K131897
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	VALES & HILLS BIOMEDICAL TECH. LTD. P.O. BOX 120-119 SHANGHAI 200120 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	06/25/2013
Decision Date	11/26/2013
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