The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Agilia Sp Infusion System, Agilia Sp Mc Wifi Infusion Pump, Agilia Link, Agilia Duo, Agilia Usb Cable.
| Device ID | K210074 |
| 510k Number | K210074 |
| Device Name: | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable |
| Classification | Pump, Infusion |
| Applicant | Fresenius Kabi AG Else-Kroner-Str. 1 Bad Homburg, DE 61346 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn Fresenius Kabi LLC, USA 3 Corporate Dr Suite 300 Lake Zurich, IL 60047 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-12 |
| Decision Date | 2022-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000856058 | K210074 | 000 |