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

    AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K093262 · Decision Jul 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    267

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    Basic Information

    Device Name
    AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K093262
    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
    October 19, 2009
    Decision Date
    July 13, 2010
    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 Andon Medical Co., Ltd.

    K Number Device Name
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    K110017 AG-608N BLOOD GLUCOSE MONITORING SYSTEM
    K112738 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
    K102678 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
    K101307 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
    K093755 AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM
    K102609 KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR