BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER

    K Number: K933144 · Decision Oct 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    43
    Review Days
    106

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    Basic Information

    Device Name
    GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER
    K Number
    K933144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Imed Corp.
    Date Received
    June 28, 1993
    Decision Date
    October 12, 1993
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

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    Other Clearances by Imed Corp.

    K Number Device Name
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    K951922 ADMINISTRATION SETS WITH BALL FLOAT
    K950419 THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
    K944320 VENTED/NON-VENTED GEMINI ADMINISTRATION SET
    K945070 VERSASAE PLASTIC CANNULA- 11 GAUGE
    K931173 PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH
    K924718 SHROUDED NEEDLE DEVICES
    K921378 IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
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