Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1560](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1560) → HCJ — Device, Skin Potential Measurement

# HCJ · Device, Skin Potential Measurement

_Neurology · 21 CFR 882.1560 · Class 2_

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

## Overview

- **Product Code:** HCJ
- **Device Name:** Device, Skin Potential Measurement
- **Regulation:** [21 CFR 882.1560](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1560)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832067](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCJ/K832067.md) | SHARE INT'L TDM | Share Int'L | Oct 27, 1983 | SESE |
| [K823194](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/HCJ/K823194.md) | SKIN GALVANOMETER | Spelson Research Laboratories, Inc. | Jan 21, 1983 | SESE |

## Top Applicants

- Share Int'L — 1 clearance
- Spelson Research Laboratories, Inc. — 1 clearance

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

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