BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Advisor Pro Platform

    K Number: K210561 · Decision Sep 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    215

    Basic Information

    Device Name
    Advisor Pro Platform
    K Number
    K210561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1358
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DreaMed Diabetes Ltd.
    Date Received
    February 25, 2021
    Decision Date
    September 28, 2021
    Product Code
    QCC
    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
    QCC Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals

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