FDA 510(k) Application Details - K113811

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K113811
Device Name	Computer, Diagnostic, Programmable
Applicant	C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. LOWELL, MA 01851 US Other 510(k) Applications for this Company
Contact	ANASTASIA C RANDALL 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	12/23/2011
Decision Date	03/16/2012
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