510(k) K121613
K121613 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "AGILIA INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 1, 2013. 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
- May 1, 2013
- Date Received
- June 1, 2012
- 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