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510(k) Data Aggregation
K Number
K243426Device Name
Nurochek-Pro System
Manufacturer
Headsafe MFG Pty Ltd
Date Cleared
2025-03-27
(143 days)
Product Code
PIW, OMC
Regulation Number
882.1450Why 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
K231914Device Name
Nurochek-II System
Manufacturer
Headsafe MFG Pty Ltd
Date Cleared
2023-12-27
(181 days)
Product Code
PIW, OMC
Regulation Number
882.1450Why 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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