| Primary Device ID | 09357225001017 |
| NIH Device Record Key | d1822fe5-3a2e-4bd1-9f54-ef953b3334c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nurochek-Pro Headset |
| Version Model Number | Nurochek-Pro Headset Assembly (HS03-267) |
| Catalog Number | HS03-267 |
| Company DUNS | 748905226 |
| Company Name | HEADSAFE MFG PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 620 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| 09357225000034 - Nurochek-Pro | 2025-12-23 The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system co |
| 09357225001017 - Nurochek-Pro Headset | 2025-12-23The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potentials (SSVEP) via electroencephalography (EEG).
The Nurochek-Pro headset communicates to a computer via an isolated USB-A connection, of which allows for user control of the device via a custom software Application (App). The App communicates with a cloud-based Server that stores and processes Nurochek data using a proprietary classification algorithm. The product requires internet connection to login to the application and process data. |
| 09357225001017 - Nurochek-Pro Headset | 2025-12-23 The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potenti |
| 09357225002021 - Nurochek-Pro Application | 2025-12-23 The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface ( |
| 09357225002038 - Nurochek-Pro Server | 2025-12-23 The Nurochek-Pro Server is an umbrella term for backend software of the Nurochek-Pro System (HS03-369). It provides the function |
| 09357225003028 - Nurochek-Pro Soft Sensor Kit | 2025-12-23 The Nurochek-Pro Soft Sensor Kit is a non-invasive accessory intended for use with the Nurochek-Pro headset. The kit contains so |
| 09357225006029 - Nurochek-Pro Saline Solution | 2025-12-23 The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The so |