BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CamAPS FX

    K Number: K232603 · Decision May 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    CamAPS FX
    K Number
    K232603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1356
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Camdiab , Ltd.
    Date Received
    August 28, 2023
    Decision Date
    May 23, 2024
    Product Code
    QJI
    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
    QJI Interoperable Automated Glycemic Controller

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