# Burst Suppression Detection Software For Electroencephalograph
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ORT)
---
*AI Analytics · CC0 1.0*