Product Code: GZO FDA class 2 21 CFR 882.1540

Device, Galvanic Skin Response Measurement

Neurology

The Galvanic Skin Response Measurement Device is a neurological diagnostic instrument that measures changes in the electrical conductance of the skin in response to sweat gland activity, used to assess autonomic nervous system function and sometimes in psychophysiological research. It is classified as a Class 2 device (moderate risk). The product code is GZO under regulation 21 CFR 882.1540 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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FEI Numbers

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Basic Information

Product Code: GZO
Device Class: FDA class 2
Regulation Number: 882.1540
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K150804	QBioScan	Oct 19, 2015	Substantially Equivalent	Medeia, Inc.
K152216	SudoC	Sep 24, 2015	Substantially Equivalent	Ld Technology, LLC
K141872	SUDOSCAN	Nov 21, 2014	Substantially Equivalent	Impeto Medical, Inc.
K131568	SUDO PATH	Jun 28, 2013	Substantially Equivalent	Ld Technology, LLC
K111308	ZYTO HAND CRADLE	Aug 30, 2011	Substantially Equivalent	Zyto Technologies, Inc.
K102166	ELECTRO INTERSTITIAL SCAN	Dec 10, 2010	Substantially Equivalent	Ld Technology, LLC
K100233	SUDOSCAN	Jun 14, 2010	Substantially Equivalent	Impeto Medical
K053004	MSAS-VANTAGE	Jan 13, 2006	Substantially Equivalent	Biomeridian, Int.
K032935	EPI-SCAN, MODEL P 100	Nov 20, 2003	Substantially Equivalent	Edx Epi-Scan, Inc.
K023355	ASYRA	Jun 24, 2003	Substantially Equivalent	Galloway Technologies, LLC
K020360	ABR-2000	Aug 29, 2002	Substantially Equivalent	Meridian Co., Ltd.
K020567	AKUPORT M1	May 02, 2002	Substantially Equivalent	Vibrant Health
K020568	AKUPORT M-2	Apr 30, 2002	Substantially Equivalent	Vibrant Health
K020565	EAV COMBI-2	Apr 30, 2002	Substantially Equivalent	Vibrant Health
K020564	EAV KINDLING 2000S GSR DEVICE	Apr 30, 2002	Substantially Equivalent	Virbrant Health
K010897	MERIDIAN-PORTABLE	Jun 19, 2001	Substantially Equivalent	Meridian Co., Ltd.
K003480	BIOFIND	May 11, 2001	Substantially Equivalent	Bio-Scan, Inc.
K001347	MERIDIAN-II AND MERDIAN-PLUS	Nov 03, 2000	Substantially Equivalent	Meridian Co., Ltd.
K993824	MSAS PROFESSIONAL	Jan 20, 2000	Substantially Equivalent	Biomeridian, Int.
K993202	EIM-107 PREP-CHECK	Dec 17, 1999	Substantially Equivalent	General Devices
K992129	PHAZX VLD-100	Sep 17, 1999	Substantially Equivalent	Phazx Systems, Inc.
K970436	E-READER	Aug 15, 1997	Substantially Equivalent	Natural Herbal Products, Inc.
K943101	GALVANIC SKIN RESPONSE DEVICE	Oct 18, 1995	Substantially Equivalent	Global Ent.
K883112	DERMATRON SKIN RESISTANCE METER	Aug 10, 1989	Substantially Equivalent	Raymar Electronics
K874850	EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER	May 20, 1988	Substantially Equivalent	Epi-Scan Corp.
K842108	UNIVERSAL EXAMINATION TABLE	Jul 17, 1984	Substantially Equivalent	Engineering Dynamics Corp.