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

    COLORADO MEDICAL MODEL CTM-3000

    K Number: K853735 · Decision Oct 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    COLORADO MEDICAL MODEL CTM-3000
    K Number
    K853735
    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 6, 1985
    Decision Date
    October 4, 1985
    Product Code
    FIZ
    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
    FIZ Meter, Conductivity, Non-Remote

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    Other Clearances by Colorado Medical, Inc.

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    K841153 ADAPTOR HR-3000 REUSE
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