Epi-Scan Selective Tissue Conductance Meter

FDA 510(k) K874850 · Epi-Scan Corp.

Substantially Equivalent

510(k) numberK874850

Submission

Device name
Epi-Scan Selective Tissue Conductance Meter
Applicant
Epi-Scan Corp.
Russellville, AL, US
Received
December 3, 1987
Decision date
May 20, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GZO – Device, Galvanic Skin Response Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1540
Specialty
Neurology

Other 510(k)s with product code GZO

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K150804QBioScanGZO · Traditional Medeia, Inc.10/19/2015SE
K152216SudoCGZO · Special Ld Technology, LLC09/24/2015SE
K141872SudoscanGZO · Traditional Impeto Medical, Inc.11/21/2014SE
K131568Sudo PathGZO · Special Ld Technology, LLC06/28/2013SE
K111308Zyto Hand CradleGZO · Traditional Zyto Technologies, Inc.08/30/2011SE
K102166Electro Interstitial ScanGZO · Traditional Ld Technology, LLC12/10/2010SE
K100233SudoscanGZO · Traditional Impeto Medical06/14/2010SE
K053004Msas-VantageGZO · Special Biomeridian, Int.01/13/2006SE
K032935Epi-Scan, Model P 100GZO · Special Edx Epi-Scan, Inc.11/20/2003SE
K023355AsyraGZO · Traditional Galloway Technologies, LLC06/24/2003SE

Questions and answers

When was Epi-Scan Selective Tissue Conductance Meter cleared by the FDA?

Epi-Scan Selective Tissue Conductance Meter (K874850) received a 510(k) decision of Substantially Equivalent on May 20, 1988, 169 days after the submission was received.

What is the product code of K874850?

The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.