FDA 510(k) Application Details - K162793

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K162793
Device Name	Computer, Diagnostic, Programmable
Applicant	Boston Scientific Corporation 125 Cambridgepark Drive Suite 600 Cambridge, MA 01752 US Other 510(k) Applications for this Company
Contact	Regina Holmes 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	10/04/2016
Decision Date	03/10/2017
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