← Product Code [ETN](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN) · K954601

# NERVE LOCATOR/MONITOR SYSTEM MODIFICATION (K954601)

_Rln Systems, Inc. · ETN · Dec 22, 1995 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K954601

## Device Facts

- **Applicant:** Rln Systems, Inc.
- **Product Code:** [ETN](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN.md)
- **Decision Date:** Dec 22, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1820
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K954601](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETN/K954601)

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