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

    CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM

    K Number: K091820 · Decision Aug 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    69

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    Basic Information

    Device Name
    CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
    K Number
    K091820
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bayer Healthcare
    Date Received
    June 18, 2009
    Decision Date
    August 26, 2009
    Product Code
    NBW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Bayer Healthcare

    K Number Device Name
    K150942 Contour Next USB Blood Glucose Monitoring System
    K151742 Contour Next Control Solution
    K122370 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
    K121087 CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM
    K110894 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
    K111268 CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
    K062058 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
    K060470 ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080