The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Spectrum Iq Infusion System, Dose Iq Safety Software.
| Device ID | K173084 |
| 510k Number | K173084 |
| Device Name: | Spectrum IQ Infusion System, Dose IQ Safety Software |
| Classification | Pump, Infusion |
| Applicant | Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Dhiraj Bizzul |
| Correspondent | Dhiraj Bizzul Baxter Healthcare Corporation 32650 N. Wilson Road 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 | 2017-09-29 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412610900 | K173084 | 000 |