BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    Gili Pro BioSensor (also known as “Gili BioSensor System”)

    K Number: DEN200038 · Decision Apr 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    293

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    Basic Information

    Device Name
    Gili Pro BioSensor (also known as “Gili BioSensor System”)
    K Number
    DEN200038
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2786
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Continuse Biometrics , Ltd.
    Date Received
    June 12, 2020
    Decision Date
    April 1, 2021
    Product Code
    QOK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QOK Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate