# Automatic Event Detection Software For Polysomnograph With Electroencephalograph
> **Product code: OLZ** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1400
## Classification
- **FDA Product Code:** OLZ
- **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 electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user

## Market data
- **Cleared 510(k) submissions:** 36
- **Registered establishments:** 25
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OLZ)
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