Home / 510(k) Clearances / K913658

510(k) K913658

IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD by Imed Corp. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
July 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Imed Corp.

  • K960512 — GEMINI PC-ITX (November 21, 1996)
  • K953896 — THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS (March 20, 1996)
  • K950153 — VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) (August 24, 1995)
  • K951922 — ADMINISTRATION SETS WITH BALL FLOAT (July 19, 1995)
  • K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (June 21, 1995)
  • K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SET (February 14, 1995)
  • K945070 — VERSASAE PLASTIC CANNULA- 11 GAUGE (January 13, 1995)
  • K931173 — PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH (April 15, 1994)
  • K933144 — GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER (October 12, 1993)
  • K924718 — SHROUDED NEEDLE DEVICES (June 18, 1993)

Other clearances for product code MEB

  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • 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)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)