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

    ADAPTOR HR-3000 REUSE

    K Number: K841153 · Decision Jul 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    119

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    Basic Information

    Device Name
    ADAPTOR HR-3000 REUSE
    K Number
    K841153
    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
    March 19, 1984
    Decision Date
    July 16, 1984
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

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    Other Clearances by Colorado Medical, Inc.

    K Number Device Name
    K870689 HR-3000 REUSE ADAPTOR
    K870471 MODIFIED HR-3000 REUSE ADAPTOR
    K863471 COLORADO MEDICAL MODEL PTC 1000
    K853735 COLORADO MEDICAL MODEL CTM-3000
    K830190 AHR-3000 RE-USE ADAPTOR