FDA 510(k) Application Details - K163460

Device Classification Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K163460
Device Name	Recorder,Event,Implantable Cardiac,(With Arrhythmia Detection)
Applicant	MEDTRONIC,INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Laura Danielson Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2016
Decision Date	02/14/2017
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