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Epi-Scan Selective Tissue Conductance Meter

by Epi-Scan Corp. 510(k)

Active United States

510(k) K874850

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874850 Date20 May 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GZO
Device Class
Class II
Regulation
21 CFR Part 882.1540
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Epi-Scan Selective Tissue Conductance Meter is a medical device classified as a Galvanic Skin Response Measurement instrument. It measures selective tissue conductance, a noninvasive, painless assessment of electrophysiological responses related to sweat gland innervation, providing quantitative data for diagnostic evaluation in neurology.

This device is supplied as a reusable instrument and is intended for use in clinical settings, including neurology. It has received FDA 510(k) clearance under the classification code GZO, with a decision date of May 20, 1988. The meter operates by applying a weak direct current (DC) signal to restricted tissue areas, enabling objective measurements without invasive procedures. Storage and handling conditions are not specified in the regulatory data.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Epi-Scan Selective Tissue Conductance Meter used for?

    The Epi-Scan Selective Tissue Conductance Meter is a medical device classified as a Galvanic Skin Response Measurement instrument. It measures selective tissue conductance, a noninvasive, painless assessment of electrophysiological responses related to sweat gland innervation, providing quantitative data for diagnostic evaluation in neurology.

  • Is the Epi-Scan Selective Tissue Conductance Meter a single-use or reusable device?

    The Epi-Scan Selective Tissue Conductance Meter is supplied as a reusable instrument intended for use in clinical settings, including neurology. It operates by applying a weak direct current (DC) signal to restricted tissue areas, enabling objective measurements without invasive procedures.

  • What regulatory approvals does the Epi-Scan Selective Tissue Conductance Meter have?

    The Epi-Scan Selective Tissue Conductance Meter has received FDA 510(k) clearance under the classification code GZO, with a decision date of May 20, 1988. It is classified as substantially equivalent and reviewed under the neurology advisory committee.

  • How is the Epi-Scan Selective Tissue Conductance Meter supplied and stored?

    The Epi-Scan Selective Tissue Conductance Meter is supplied as a reusable instrument for clinical use. However, specific storage and handling conditions are not specified in the regulatory data provided for this device.