Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1540](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1540) → GZO — Device, Galvanic Skin Response Measurement # GZO · Device, Galvanic Skin Response Measurement _Neurology · 21 CFR 882.1540 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO ## Overview - **Product Code:** GZO - **Device Name:** Device, Galvanic Skin Response Measurement - **Regulation:** [21 CFR 882.1540](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1540) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. ## 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 (20 of 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K150804](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K150804.md) | QBioScan | Medeia, Inc. | Oct 19, 2015 | SESE | | [K152216](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K152216.md) | SudoC | Ld Technology, LLC | Sep 24, 2015 | SESE | | [K141872](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K141872.md) | SUDOSCAN | Impeto Medical, Inc. | Nov 21, 2014 | SESE | | [K131568](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K131568.md) | SUDO PATH | Ld Technology, LLC | Jun 28, 2013 | SESE | | [K111308](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K111308.md) | ZYTO HAND CRADLE | Zyto Technologies, Inc. | Aug 30, 2011 | SESE | | [K102166](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K102166.md) | ELECTRO INTERSTITIAL SCAN | Ld Technology, LLC | Dec 10, 2010 | SESE | | [K100233](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K100233.md) | SUDOSCAN | Impeto Medical | Jun 14, 2010 | SESE | | [K053004](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K053004.md) | MSAS-VANTAGE | Biomeridian, Int. | Jan 13, 2006 | SESE | | [K032935](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K032935.md) | EPI-SCAN, MODEL P 100 | Edx Epi-Scan, Inc. | Nov 20, 2003 | SESE | | [K023355](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K023355.md) | ASYRA | Galloway Technologies, LLC | Jun 24, 2003 | SESE | | [K020360](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K020360.md) | ABR-2000 | Meridian Co., Ltd. | Aug 29, 2002 | SESE | | [K020567](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K020567.md) | AKUPORT M1 | Vibrant Health | May 2, 2002 | SESE | | [K020568](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K020568.md) | AKUPORT M-2 | Vibrant Health | Apr 30, 2002 | SESE | | [K020565](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K020565.md) | EAV COMBI-2 | Vibrant Health | Apr 30, 2002 | SESE | | [K020564](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K020564.md) | EAV KINDLING 2000S GSR DEVICE | Virbrant Health | Apr 30, 2002 | SESE | | [K010897](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K010897.md) | MERIDIAN-PORTABLE | Meridian Co., Ltd. | Jun 19, 2001 | SESE | | [K003480](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K003480.md) | BIOFIND | Bio-Scan, Inc. | May 11, 2001 | SESE | | [K001347](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K001347.md) | MERIDIAN-II AND MERDIAN-PLUS | Meridian Co., Ltd. | Nov 3, 2000 | SESE | | [K993824](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K993824.md) | MSAS PROFESSIONAL | Biomeridian, Int. | Jan 20, 2000 | SESE | | [K993202](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K993202.md) | EIM-107 PREP-CHECK | General Devices | Dec 17, 1999 | SESE | ## Top Applicants - Ld Technology, LLC — 3 clearances - Meridian Co., Ltd. — 3 clearances - Vibrant Health — 3 clearances - Biomeridian, Int. — 2 clearances - Bio-Scan, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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