Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1880](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1880) → GZP — Stimulator, Mechanical, Evoked Response

# GZP · Stimulator, Mechanical, Evoked Response

_Neurology · 21 CFR 882.1880 · Class 2_

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

## Overview

- **Product Code:** GZP
- **Device Name:** Stimulator, Mechanical, Evoked Response
- **Regulation:** [21 CFR 882.1880](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1880)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K191700](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP/K191700.md) | EyeStat | Blinktbi, Inc. | Dec 9, 2019 | SESE |
| [K913604](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP/K913604.md) | SOMATOSENSORY STIMULUS SYSTEM | Biomagnetic Technologies, Inc. | Dec 9, 1991 | SESE |

## Top Applicants

- Biomagnetic Technologies, Inc. — 1 clearance
- Blinktbi, Inc. — 1 clearance

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

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