ORT

Burst Suppression Detection Software For Electroencephalograph

Product code

ORT

Device name

Burst Suppression Detection Software For Electroencephalograph

Device class

Class 2

21 CFR

21 CFR 882.1400

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).