FDA 510(k) Application Details - K181502

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K181502
Device Name	Computer, Diagnostic, Programmable
Applicant	iRhythm Technologies, Inc. 650 Townsend Street, Suite 500 San Francisco, CA 94103 US Other 510(k) Applications for this Company
Contact	Rich Laguna Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2018
Decision Date	08/29/2018
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