BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000

    K Number: K921168 · Decision Apr 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    34
    Applicant Total
    5
    Review Days
    407

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    Basic Information

    Device Name
    ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
    K Number
    K921168
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allen Medical Systems, Inc.
    Date Received
    March 10, 1992
    Decision Date
    April 21, 1993
    Product Code
    KZD
    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
    KZD Infusor, Pressure, For I.V. Bags

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