K173084 is an FDA 510(k) clearance for the Spectrum IQ Infusion System, 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 May 11, 2018, 224 days after receiving the submission on September 29, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K173084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | May 11, 2018 |
| Days to Decision | 224 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 |