K183311 is an FDA 510(k) clearance for the Ivenix Infusion System (IIS). This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Ivenix, Inc. (North Andover, US). The FDA issued a Cleared decision on June 7, 2019, 190 days after receiving the submission on November 29, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K183311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2018 |
| Decision Date | June 07, 2019 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |