BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK

    K Number: K852938 · Decision Sep 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
    K Number
    K852938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Northern Customfab, Inc.
    Date Received
    July 10, 1985
    Decision Date
    September 30, 1985
    Product Code
    KPE
    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
    KPE Container, I.V.

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    Other Clearances by Northern Customfab, Inc.

    K Number Device Name
    K852937 THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K