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510(k) K032147

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES by Alaris Medical Systems, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2003
Date Received
July 14, 2003
Clearance Type
Special
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 Alaris Medical Systems, Inc.

  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (July 6, 2004)
  • K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (February 9, 2004)
  • K032233 — MEDLEY PCA MODULE, MODEL 8120 (September 9, 2003)
  • K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (April 4, 2003)
  • K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (December 19, 2002)
  • K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (September 11, 2002)
  • K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS (August 6, 2002)
  • K013087 — SINGLE DOSE DISPENSING PIN, MODEL 2201 (November 13, 2001)
  • K012383 — GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM I (October 2, 2001)

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