ARTG 476310Bioelectrical signal processing application software
ARTG ID: 476310 · Natus Medical Pty Ltd · Micromed SPA · Class IIb · Started January 21, 2025
Good Name: Natus Medical Pty Ltd - Bioelectrical signal processing application software
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 476310
- Start Date
- January 21, 2025
- Effective Date
- January 21, 2025
- Name
- Micromed SPA
- Country
- Italy
- Address
- Mogliano Veneto, via Giotto 2, 31021
BRAIN QUICK Software is intended to acquire scalp and intracranial electroencephalographic (EEG) signals and polysomnographic (PSG) signals. It is also able to drive a cortical stimulator and monitor other physiological measurements coming from third-party interfaced medical devices. Electroencephalography and Polysomnography consist in the recording of electrical activity of the brain, together with other physiological parameters, and they can be used for neurophysiological studies and analysis, as diagnostic aid for the evaluation of disturbances of the functions of the Central Nervous System. When a cortical stimulator is used, the software can be also be used as help in the preliminary or intraoperative localization of the intervention sites for epilepsy surgery (stereoEEG). In order to display and analyze the recorded signals, the software must work in combination with Micromed SD devices. The software does not make any judgment of normality or abnormality from displayed signals or the result of an analysis. None of the functions of the software are considered in themselves diagnostic
Access comprehensive regulatory information for Bioelectrical signal processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476310 and sponsored by Natus Medical Pty Ltd, manufactured by Micromed SPA in Italy. The device registration started on January 21, 2025.
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