FDA 510(k) Application Details - K151613

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K151613
Device Name	Computer, Diagnostic, Programmable
Applicant	BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311 US Other 510(k) Applications for this Company
Contact	ARLENE ROCHE 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	06/15/2015
Decision Date	10/06/2015
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