FDA 510(k) Application Details - K163407

Device Classification Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)   More FDA Info for this Device
510(K) Number	K163407
Device Name	Recorder,Event,Implantable Cardiac,(Without Arrhythmia Detection)
Applicant	St. Jude Medical, Inc. 15900 Valley View Ct. Sylmar, CA 91342 US Other 510(k) Applications for this Company
Contact	Jennifer Dunham 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	12/05/2016
Decision Date	09/29/2017
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