← Product Code [OLW](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW) · K002837

# BIS ENGINE (K002837)

_Aspect Medical Systems, Inc. · OLW · Sep 19, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K002837

## Device Facts

- **Applicant:** Aspect Medical Systems, Inc.
- **Product Code:** [OLW](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW.md)
- **Decision Date:** Sep 19, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 882.1400
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K002837](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/OLW/K002837)

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