FDA 510(k) Application Details - K060980

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K060980
Device Name	Computer, Diagnostic, Programmable
Applicant	ENDOTHELIX, INC. 2472 BOLSOVER SUITE 439C HOUSTON, TX 77005 US Other 510(k) Applications for this Company
Contact	DOUGLAS BLAKELY 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	04/10/2006
Decision Date	08/16/2007
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