BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951

    K Number: K101307 · Decision Aug 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    178
    Same Product Code
    506
    Applicant Total
    8
    Review Days
    456

    Basic Information

    Device Name
    BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
    K Number
    K101307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ANDON MEDICAL CO., LTD.
    Date Received
    May 10, 2010
    Decision Date
    August 9, 2011
    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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