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510(k) K211124

Dose IQ Safety Software by Baxter Healthcare Corporation — Product Code PHC

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.

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Other clearances for product code PHC

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  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K223606 — LifeShield™ Infusion Safety Software Suite (August 24, 2023)
  • K210075 — Vigilant Software Suite – Vigilant Master Med (March 1, 2022)
  • K182092 — BD Intelliport System (April 30, 2019)
  • K141474 — BECTON DICKINSON INTELLIPORT SYSTEM (December 18, 2014)
  • K141193 — MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSI (July 25, 2014)