Burst Suppression Detection Software For Electroencephalograph

ORT · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1400

Classification

FDA Product Code: ORT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1400
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 47

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown