510(k) K210075
K210075 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "Vigilant Software Suite Vigilant Master Med". The FDA issued a decision of Substantially Equivalent on March 1, 2022. The device falls under product code PHC (Infusion Safety Management Software), a Class II device regulated under 21 CFR 880.5725. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2022
- Date Received
- January 12, 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.