510(k) K210073
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