GZO · Device, Galvanic Skin Response Measurement
Neurology · 21 CFR 882.1540 · Class 2
Overview
| Product Code | GZO |
|---|---|
| Device Name | Device, Galvanic Skin Response Measurement |
| Regulation | 21 CFR 882.1540 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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 | QBioScan | Medeia, Inc. | Oct 19, 2015 | SESE |
| K152216 | SudoC | Ld Technology, LLC | Sep 24, 2015 | SESE |
| K141872 | SUDOSCAN | Impeto Medical, Inc. | Nov 21, 2014 | SESE |
| K131568 | SUDO PATH | Ld Technology, LLC | Jun 28, 2013 | SESE |
| K111308 | ZYTO HAND CRADLE | Zyto Technologies, Inc. | Aug 30, 2011 | SESE |
| K102166 | ELECTRO INTERSTITIAL SCAN | Ld Technology, LLC | Dec 10, 2010 | SESE |
| K100233 | SUDOSCAN | Impeto Medical | Jun 14, 2010 | SESE |
| K053004 | MSAS-VANTAGE | Biomeridian, Int. | Jan 13, 2006 | SESE |
| K032935 | EPI-SCAN, MODEL P 100 | Edx Epi-Scan, Inc. | Nov 20, 2003 | SESE |
| K023355 | ASYRA | Galloway Technologies, LLC | Jun 24, 2003 | SESE |
| K020360 | ABR-2000 | Meridian Co., Ltd. | Aug 29, 2002 | SESE |
| K020567 | AKUPORT M1 | Vibrant Health | May 2, 2002 | SESE |
| K020568 | AKUPORT M-2 | Vibrant Health | Apr 30, 2002 | SESE |
| K020565 | EAV COMBI-2 | Vibrant Health | Apr 30, 2002 | SESE |
| K020564 | EAV KINDLING 2000S GSR DEVICE | Virbrant Health | Apr 30, 2002 | SESE |
| K010897 | MERIDIAN-PORTABLE | Meridian Co., Ltd. | Jun 19, 2001 | SESE |
| K003480 | BIOFIND | Bio-Scan, Inc. | May 11, 2001 | SESE |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Meridian Co., Ltd. | Nov 3, 2000 | SESE |
| K993824 | MSAS PROFESSIONAL | Biomeridian, Int. | Jan 20, 2000 | SESE |
| K993202 | 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
