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510(k) K243855

BD Alaris Infusion System with Guardrails Suite MX by Carefusion 303, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
December 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Carefusion 303, Inc.

  • K211218 — BD Alaris System with Guardrails Suite MX v12.1.2 (July 21, 2023)
  • K171957 — MaxZero Extension Sets with Needless Connector (July 19, 2017)
  • K163316 — Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (June 22, 2017)
  • K133532 — ALARIS SYSTEM WITH GUARDRAILS SUITE MX (August 21, 2014)
  • K110535 — ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION (March 26, 2012)
  • K110809 — WIRELESS MONITORING SYSTEM (July 5, 2011)

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