ORT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Burst Suppression Detection Software For Electroencephalograph

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1400

Medical specialty

Neurology

FDA definition

Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user.

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