FDA 510(k) Application Details - K091075

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K091075
Device Name	Computer, Diagnostic, Programmable
Applicant	IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 SAN FRANCISCO, CA 94103 US Other 510(k) Applications for this Company
Contact	MICHAEL RIGHTER 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	04/14/2009
Decision Date	07/21/2009
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