Pure Global

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Automatic Event Detection Software For Polysomnograph With Electroencephalograph is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Neurology Medical Device Type
Pure Global
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Regulatory Classifications

US Regulatory Classifications

OLZ

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Class 2

21 CFR 882.1400

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Neurology

Device Characteristics

No

No

No

Not Eligible

Definition

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