The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Spectrum Iq Infusion System With Dose Iq Safety Software.
| Device ID | K220417 |
| 510k Number | K220417 |
| Device Name: | Spectrum IQ Infusion System With Dose IQ Safety Software |
| Classification | Pump, Infusion |
| Applicant | Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Contact | Jennifer Hoogheem |
| Correspondent | Jennifer Hoogheem Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-04-29 |