BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PORT-A-POLE

    K Number: K961470 · Decision Jul 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    278
    Registration Numbers
    278
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    96

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    Basic Information

    Device Name
    PORT-A-POLE
    K Number
    K961470
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6990
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Prins Medical Ind., Inc.
    Date Received
    April 17, 1996
    Decision Date
    July 22, 1996
    Product Code
    FOX
    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
    FOX Stand, Infusion

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