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510(k) Data Aggregation

    K Number
    K180524
    Device Name
    EEG-Now
    Manufacturer
    EncephaloDynamics, Inc.
    Date Cleared
    2018-05-18

    (80 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    EncephaloDynamics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An electroencephalogram (EEG) electrode array intended for use in the ER, ICU, and OR for recording of STAT EEGs in patients of 18 years of age and older.
    Device Description
    An electroencephalogram (EEG) electrode array
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