510(k) K211124
K211124 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Dose IQ Safety Software". The FDA issued a decision of Substantially Equivalent on August 30, 2022. The device falls under product code PHC (Infusion Safety Management Software), a Class II device regulated under 21 CFR 880.5725. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2022
- Date Received
- April 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infusion Safety Management Software
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.