← Product Code [GXZ](/productcode/GXZ) · K900740

# SPECIMEX DC (K900740)

_Soredex Medical Systems · GXZ · May 11, 1990 · Neurology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K900740

## Device Facts

- **Applicant:** Soredex Medical Systems
- **Product Code:** [GXZ](/productcode/GXZ.md)
- **Decision Date:** May 11, 1990
- **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-staging.innolitics.com/device/K900740](https://fda-staging.innolitics.com/device/K900740)

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