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510(k) K051641

ALARIS SYSTEM PC UNIT, MODEL 8001 by Cardinal Health, Alaris Products — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2005
Date Received
June 20, 2005
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 Cardinal Health, Alaris Products

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  • K053049 — ALARIS SAFETY MALE LUER (January 12, 2006)
  • K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (December 23, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K043590 — SE INFUSION SYSTEM WITH MMS (March 25, 2005)
  • K050230 — TURBO TEMP TRIO (February 16, 2005)

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