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Sources: EU EUDAMED, US FDA
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SEE-MODE TECHNOLOGIES PTY LTD
FDA registration
SEE-MODE TECHNOLOGIES PTY LTD·3 products·🇦🇺 Australia
Seer Medical Holdings Limited
Manufacturer
🇦🇺 Australia
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Enforcement
Class II
·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024