BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇬🇧 United Kingdom

    3400 INFUSION PUMP

    K Number: K931318 · Decision Dec 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    5
    Review Days
    633

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    Basic Information

    Device Name
    3400 INFUSION PUMP
    K Number
    K931318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Graseby Medical , Ltd.
    Date Received
    March 16, 1993
    Decision Date
    December 9, 1994
    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 Graseby Medical , Ltd.

    K Number Device Name
    K944721 9000 INFUSION PUMP
    K915270 PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
    K912192 3100 INFUSION PUMP
    K912193 3000 INFUSION PUMP