FDA product code OMB

Automatic Event Detection Software For Full-Montage Electroencephalograph

Neurology·Class 2·21 CFR 882.1400
US regulatory classifications
US Product Code (FDA)
OMB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.1400
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

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About this record

Automatic Event Detection Software For Full-Montage 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.