BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COLORADO MEDICAL MODEL PTC 1000

    K Number: K863471 · Decision Oct 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    COLORADO MEDICAL MODEL PTC 1000
    K Number
    K863471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Colorado Medical, Inc.
    Date Received
    September 9, 1986
    Decision Date
    October 2, 1986
    Product Code
    KXM
    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
    KXM System Accessories, Extracorporeal

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