FDA 510(k) Application Details - K062508

Device Classification Name	Ultrasound, Infusion, System   More FDA Info for this Device
510(K) Number	K062508
Device Name	Ultrasound, Infusion, System
Applicant	EKOS CORP. 11911 NORTH CREEK PKWY. SOUTH BOTHELL, WA 98011 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	08/28/2006
Decision Date	12/05/2006
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review