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

    MSI PRESSURE INFUSOR

    K Number: K973843 · Decision Oct 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    MSI PRESSURE INFUSOR
    K Number
    K973843
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smith Assoc.
    Date Received
    October 8, 1997
    Decision Date
    October 29, 1997
    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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