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

    AMBULATORY INFUSION PUMP

    K Number: K890862 · Decision Aug 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    5
    Review Days
    163

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    Basic Information

    Device Name
    AMBULATORY INFUSION PUMP
    K Number
    K890862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medfusion, Inc.
    Date Received
    February 21, 1989
    Decision Date
    August 3, 1989
    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 Medfusion, Inc.

    K Number Device Name
    K905783 MODIFIED WALKMED 400
    K905029 MODEL 2001, MODIFICATION
    K901755 MODEL 3001 SYRINGE INFUSION PUMP
    K890120 SYRINGE INFUSION PUMP