Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1340](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1340) → GZK — Electrode, Nasopharyngeal

# GZK · Electrode, Nasopharyngeal

_Neurology · 21 CFR 882.1340 · Class 2_

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

## Overview

- **Product Code:** GZK
- **Device Name:** Electrode, Nasopharyngeal
- **Regulation:** [21 CFR 882.1340](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1340)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K030517](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZK/K030517.md) | BALL RECORDING ELECTRODE/STIMULATION PROBE | Viasys Healthcare, Inc. | Aug 1, 2003 | SESE |
| [K830325](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZK/K830325.md) | TIGER PULSE | Bertone & Assoc. | Mar 1, 1983 | SESE |

## Top Applicants

- Bertone & Assoc. — 1 clearance
- Viasys Healthcare, Inc. — 1 clearance

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

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