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510(k) K043590

SE INFUSION SYSTEM WITH MMS by Cardinal Health, Alaris Products — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2005
Date Received
December 28, 2004
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

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  • K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001 (October 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K050230 — TURBO TEMP TRIO (February 16, 2005)

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