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

    GO MEDICAL BALLOON INFUSION SYSTEM

    K Number: K000263 · Decision May 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    11
    Review Days
    102

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    Basic Information

    Device Name
    GO MEDICAL BALLOON INFUSION SYSTEM
    K Number
    K000263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Go Medical Industries Pty. , Ltd.
    Date Received
    January 28, 2000
    Decision Date
    May 9, 2000
    Product Code
    MEB
    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
    MEB Pump, Infusion, Elastomeric

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