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

    SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM

    K Number: K060933 · Decision May 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    34

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    Basic Information

    Device Name
    SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
    K Number
    K060933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apex Medical Technologies, Inc.
    Date Received
    April 5, 2006
    Decision Date
    May 9, 2006
    Product Code
    MEB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MEB Pump, Infusion, Elastomeric

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