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510(k) K081905

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP by Westmed, Inc. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2008
Date Received
July 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Westmed, Inc.

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  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K133057 — VIBRALUNG ACOUSTICAL PERCUSSOR (May 23, 2014)
  • K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] (December 6, 2012)
  • K072220 — PEDI CO2 EASY (August 23, 2007)
  • K070128 — CO2 EASY (February 15, 2007)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)

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  • K151650 — SMARTez elastomeric infusion pump (April 4, 2016)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)
  • K072053 — SMARTBLOCK PAIN PUMP (November 6, 2007)