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510(k) K043299

MEDLEY PCA MODULE, MODEL 8120 by Alaris Medical Systems, Inc. — Product Code MEA

K043299 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "MEDLEY PCA MODULE, MODEL 8120". The FDA issued a decision of Substantially Equivalent on December 10, 2004. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2004
Date Received
November 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Alaris Medical Systems, Inc.

  • 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)
  • K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 7 (July 25, 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)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (November 4, 2009)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (October 18, 2004)
  • K033054 — HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (December 16, 2003)

FDA data resources