BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

    K Number: K020418 · Decision Apr 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    446

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    Basic Information

    Device Name
    GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    K Number
    K020418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Greenleaf
    Date Received
    February 7, 2002
    Decision Date
    April 29, 2003
    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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    Other Clearances by P.T. Greenleaf

    K Number Device Name
    K020419 V SET