FDA 510(k) Application Details - K143513

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K143513
Device Name	Recorder, Magnetic Tape, Medical
Applicant	iRhythm Technologies, Inc. 650 Townsend Street, Ste 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	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2014
Decision Date	06/19/2015
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