FDA 510(k) Application Details - K103706

Device Classification Name	More FDA Info for this Device
510(K) Number	K103706
Device Name	THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
Applicant	APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills, CA 92653 US Other 510(k) Applications for this Company
Contact	R. BEN GHADIMI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2010
Decision Date	08/24/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review