The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Dose Iq Safety Software.
| Device ID | K211124 |
| 510k Number | K211124 |
| Device Name: | Dose IQ Safety Software |
| Classification | Infusion Safety Management Software |
| Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
| Contact | Michelle Rixie |
| Correspondent | Michelle Rixie Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
| Product Code | PHC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-15 |
| Decision Date | 2022-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412676616 | K211124 | 000 |