FDA 510(k) Application Details - K183319

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K183319
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Prabhu Raghavan Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2018
Decision Date	05/10/2019
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