Galvanic Skin Response Device

FDA 510(k) K943101 · Global Ent.

Substantially Equivalent

510(k) numberK943101

Submission

Device name
Galvanic Skin Response Device
Applicant
Global Ent.
Orem, UT, US
Received
June 29, 1994
Decision date
October 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 Galvanic Skin Response Device cleared by the FDA?

Galvanic Skin Response Device (K943101) received a 510(k) decision of Substantially Equivalent on October 18, 1995, 476 days after the submission was received.

What is the product code of K943101?

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