The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Agilia Infusion System.
| Device ID | K121613 |
| 510k Number | K121613 |
| Device Name: | AGILIA INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | FRESENIUS KABI AG THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Contact | Cheryl Roscher |
| Correspondent | Cheryl Roscher FRESENIUS KABI AG THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250273733891 | K121613 | 000 |
| 4250273714364 | K121613 | 000 |
| 4250273714340 | K121613 | 000 |
| 4250273714326 | K121613 | 000 |
| 4250273714302 | K121613 | 000 |
| 4250273714289 | K121613 | 000 |
| 4250273714265 | K121613 | 000 |
| 04250273714234 | K121613 | 000 |
| 4250273714197 | K121613 | 000 |
| 04086000852074 | K121613 | 000 |
| 04086000851831 | K121613 | 000 |
| 04086000851794 | K121613 | 000 |
| 04052682034121 | K121613 | 000 |
| 04250273717655 | K121613 | 000 |
| 4250273714388 | K121613 | 000 |
| 4250273714401 | K121613 | 000 |
| 04250273733860 | K121613 | 000 |
| 04250273731972 | K121613 | 000 |
| 04250273731958 | K121613 | 000 |
| 04250273731910 | K121613 | 000 |
| 04250273731897 | K121613 | 000 |
| 04250273731873 | K121613 | 000 |
| 04250273731859 | K121613 | 000 |
| 4250273714821 | K121613 | 000 |
| 04250273714517 | K121613 | 000 |
| 4250273714500 | K121613 | 000 |
| 4250273714487 | K121613 | 000 |
| 4250273714463 | K121613 | 000 |
| 4250273714449 | K121613 | 000 |
| 04250273713626 | K121613 | 000 |