FDA 510(k) Application Details - K080954

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K080954
Device Name	Pump, Infusion
Applicant	CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK CAESAREA 38900 IL Other 510(k) Applications for this Company
Contact	EVA PARTAS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2008
Decision Date	05/16/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review