← Product Code [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF) · K851300

# NEUROPACK 8, MEE-4108 (K851300)

_Nihon Kohden America, Inc. · GWF · Jun 13, 1985 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K851300

## Device Facts

- **Applicant:** Nihon Kohden America, Inc.
- **Product Code:** [GWF](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF.md)
- **Decision Date:** Jun 13, 1985
- **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/K851300](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K851300)

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