← Product Code [GWJ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ) · K960097

# CHARTR EP (K960097)

_Ics Medical Corp. · GWJ · Feb 21, 1997 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K960097

## Device Facts

- **Applicant:** Ics Medical Corp.
- **Product Code:** [GWJ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ.md)
- **Decision Date:** Feb 21, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1900
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K960097](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWJ/K960097)

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