FDA 510(k) Application Details - K043269

Device Classification Name	More FDA Info for this Device
510(K) Number	K043269
Device Name	Lysus 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	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2004
Decision Date	12/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review