FDA 510(k) Application Details - K213409

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K213409
Device Name	Computer, Diagnostic, Programmable
Applicant	iRhythm Technologies, Inc. 699 8th Street, Suite 600 San Francisco, CA 94103 US Other 510(k) Applications for this Company
Contact	Vishal Kanani 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	10/19/2021
Decision Date	07/19/2022
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