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Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA product code OLZ · 35 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1400
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1986-10-06 – 2026-06-27

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

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