FDA 510(k) Application Details - K043299

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K043299
Device Name	Pump, Infusion, Pca
Applicant	ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	STACY L LEWIS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2004
Decision Date	12/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review