← Product Code [GXZ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ) · K850107

# CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (K850107)

_Nicolet Biomedical Instruments · GXZ · Apr 11, 1985 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K850107

## Device Facts

- **Applicant:** Nicolet Biomedical Instruments
- **Product Code:** [GXZ](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ.md)
- **Decision Date:** Apr 11, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1350
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K850107](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXZ/K850107)

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