← Product Code [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF) · K001101

# XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 (K001101)

_Excel Tech. , Ltd. · GWF · Jun 30, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K001101

## Device Facts

- **Applicant:** Excel Tech. , Ltd.
- **Product Code:** [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF.md)
- **Decision Date:** Jun 30, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1870
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K001101](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K001101)

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