FDA 510(k) Application Details - K130921

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K130921
Device Name	Electrocardiograph
Applicant	ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR SAN FRANCISCO, CA 94108 US Other 510(k) Applications for this Company
Contact	MICHAEL RIGHTER Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2013
Decision Date	02/06/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review