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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device burst suppression detection software for electroencephalograph
Regulation Description Electroencephalograph.
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.
Product CodeORT
Regulation Number 882.1400
Device Class 2