BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Entropy Module, E-ENTROPY-01

    K Number: K150298 · Decision Nov 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    279

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    Basic Information

    Device Name
    Entropy Module, E-ENTROPY-01
    K Number
    K150298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare Filand OY
    Date Received
    February 6, 2015
    Decision Date
    November 12, 2015
    Product Code
    OLW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    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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