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510(k) Data Aggregation

    K Number
    K243426
    Device Name
    Nurochek-Pro System
    Manufacturer
    Headsafe MFG Pty Ltd
    Date Cleared
    2025-03-27

    (143 days)

    Product Code
    PIW, OMC
    Regulation Number
    882.1450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Headsafe MFG Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nurochek-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old. for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain iniury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
    Device Description
    The Nurochek-Pro System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities, by healthcare professionals, on subjects aged between 12 and 44 years old, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-Pro System are the wearable headset, the Nurochek-Pro Software Application, and the Nurochek-Pro Server.
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    K Number
    K231914
    Device Name
    Nurochek-II System
    Manufacturer
    Headsafe MFG Pty Ltd
    Date Cleared
    2023-12-27

    (181 days)

    Product Code
    PIW, OMC
    Regulation Number
    882.1450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Headsafe MFG Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).
    Device Description
    The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.
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