FDA 510(k) Application Details - K053194

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K053194
Device Name	Computer, Diagnostic, Programmable
Applicant	BIOSENSE WEBSTER, INC. 2400 VIA CARRILLO PALOS VERDES ESTATES, CA 90274 US Other 510(k) Applications for this Company
Contact	SIGI CARON 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	11/15/2005
Decision Date	03/09/2006
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