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

    LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS

    K Number: K091181 · Decision Jun 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    20
    Review Days
    50

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    Basic Information

    Device Name
    LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
    K Number
    K091181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical MD, Inc.
    Date Received
    April 23, 2009
    Decision Date
    June 12, 2009
    Product Code
    MRZ
    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
    MRZ Accessories, Pump, Infusion

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