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510(k) K960512

GEMINI PC-ITX by Imed Corp. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1996
Date Received
February 5, 1996
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 Imed Corp.

  • 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)
  • K921378 — IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE (June 9, 1992)

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