K220417 is an FDA 510(k) clearance for the Spectrum IQ Infusion System with Dose IQ Safety Software. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on April 29, 2022, 74 days after receiving the submission on February 14, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K220417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | April 29, 2022 |
| Days to Decision | 74 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 |