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

    WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4

    K Number: K101597 · Decision Oct 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    7
    Review Days
    132

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    Basic Information

    Device Name
    WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
    K Number
    K101597
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agamatrix
    Date Received
    June 8, 2010
    Decision Date
    October 18, 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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