FDA 510(k) Application Details - K053437

Device Classification Name	Ultrasound, Infusion, System   More FDA Info for this Device
510(K) Number	K053437
Device Name	Ultrasound, Infusion, System
Applicant	EKOS CORP. 22030 20TH AVENUE S.E. SUITE 101 BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	JOCELYN KERSTEN Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	NUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2005
Decision Date	01/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review