FDA 510(k) Application Details - K153160

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K153160
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	MEDTRONIC, INC. 8200 CORAL SEA STREET NE MOUNDS VIEW, MN 55112 US Other 510(k) Applications for this Company
Contact	CHERYL L. SWANSON Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2015
Decision Date	03/30/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review