AGILIA INFUSION SYSTEM


Device Classification Name

pump, infusion

510(k) Number K121613
Device Name AGILIA INFUSION SYSTEM
Applicant
FRESENIUS KABI AG
three corporate drive
lake zurich, 
IL 
60047

Applicant Contact cheryl roscher
Correspondent
FRESENIUS KABI AG
three corporate drive
lake zurich, 
IL 
60047

Correspodent Contact cheryl roscher
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 06/01/2012
Decision Date 05/01/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No