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

    AVIA PAIN MEDICATION DELIVERY SYSTEM

    K Number: K990312 · Decision Apr 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    AVIA PAIN MEDICATION DELIVERY SYSTEM
    K Number
    K990312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amtec Medical
    Date Received
    February 1, 1999
    Decision Date
    April 22, 1999
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

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