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

    CART, MODE NUMBER UDS-CART

    K Number: K950016 · Decision Mar 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    CART, MODE NUMBER UDS-CART
    K Number
    K950016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laborie Medical Tech Corp.
    Date Received
    January 3, 1995
    Decision Date
    March 30, 1995
    Product Code
    FEN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FEN Device, Cystometric, Hydraulic

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