BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Brain Anesthesia Response Monitor (Bar Monitor)

    K Number: K213273 · Decision Sep 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    701

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    Basic Information

    Device Name
    Brain Anesthesia Response Monitor (Bar Monitor)
    K Number
    K213273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cortical Dynamics , Ltd.
    Date Received
    September 30, 2021
    Decision Date
    September 1, 2023
    Product Code
    OLW
    Advisory Committee
    Neurology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLW Index-Generating Electroencephalograph Software

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