510(k) K210075

Vigilant Software Suite Vigilant Master Med by Fresenius Kabi AG — Product Code PHC

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.

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