FDA 510(k) Application Details - K133481

Device Classification Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K133481
Device Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant	ST. JUDE MEDICAL, INC. 645 ALMANOR AVENUE SUNNYVALE, CA 94085-2927 US Other 510(k) Applications for this Company
Contact	Michael McSweeney Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2013
Decision Date	05/28/2014
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