FDA 510(k) Application Details - K163512

Device Classification Name	More FDA Info for this Device
510(K) Number	K163512
Device Name	Zio AT ECG Monitoring System
Applicant	IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 SAN FRANCISCO, CA 94103 US Other 510(k) Applications for this Company
Contact	RICH LAGUNA 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	12/15/2016
Decision Date	06/02/2017
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