FDA 510(k) Application Details - K181918

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K181918
Device Name	Computer, Diagnostic, Programmable
Applicant	Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Janell Colley Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2018
Decision Date	11/08/2018
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