510(k) K210073

Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo by Fresenius Kabi AG — Product Code FRN

K210073 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo". The FDA issued a decision of Substantially Equivalent on March 1, 2022. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2022
Date Received
January 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type