FDA 510(k) Application Details - K122356

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K122356
Device Name	Electrocardiograph
Applicant	ALIVECOR, INC. 140 GEARY STREET SUITE 500 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	08/03/2012
Decision Date	11/19/2012
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