GZO
26 FDA 510(k) clearances · Product code
112 daysmedian time to decision
260 days90th percentile
26clearances measured
FDA profile
- Official device name
- Device, Galvanic Skin Response Measurement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1540
- Medical specialty
- Neurology
- Adverse events (MAUDE)
- 1999: 1 · 2001: 1 · 2002: 1 · 2018: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QBioScan (K150804) | Medeia, Inc. | 2015-10-19 |
| SudoC (K152216) | Ld Technology, LLC | 2015-09-24 |
| SUDOSCAN (K141872) | Impeto Medical, Inc. | 2014-11-21 |
| SUDO PATH (K131568) | Ld Technology, LLC | 2013-06-28 |
| ZYTO HAND CRADLE (K111308) | Zyto Technologies, Inc. | 2011-08-30 |
| ELECTRO INTERSTITIAL SCAN (K102166) | Ld Technology, LLC | 2010-12-10 |
| SUDOSCAN (K100233) | Impeto Medical | 2010-06-14 |
| MSAS-VANTAGE (K053004) | Biomeridian, Int. | 2006-01-13 |
| EPI-SCAN, MODEL P 100 (K032935) | Edx Epi-Scan, Inc. | 2003-11-20 |
| ASYRA (K023355) | Galloway Technologies, LLC | 2003-06-24 |
| ABR-2000 (K020360) | Meridian Co., Ltd. | 2002-08-29 |
| AKUPORT M1 (K020567) | Vibrant Health | 2002-05-02 |
| EAV KINDLING 2000S GSR DEVICE (K020564) | Virbrant Health | 2002-04-30 |
| AKUPORT M-2 (K020568) | Vibrant Health | 2002-04-30 |
| EAV COMBI-2 (K020565) | Vibrant Health | 2002-04-30 |
| MERIDIAN-PORTABLE (K010897) | Meridian Co., Ltd. | 2001-06-19 |
| BIOFIND (K003480) | Bio-Scan, Inc. | 2001-05-11 |
| MERIDIAN-II AND MERDIAN-PLUS (K001347) | Meridian Co., Ltd. | 2000-11-03 |
| MSAS PROFESSIONAL (K993824) | Biomeridian, Int. | 2000-01-20 |
| EIM-107 PREP-CHECK (K993202) | General Devices | 1999-12-17 |
| PHAZX VLD-100 (K992129) | Phazx Systems, Inc. | 1999-09-17 |
| E-READER (K970436) | Natural Herbal Products, Inc. | 1997-08-15 |
| GALVANIC SKIN RESPONSE DEVICE (K943101) | Global Ent. | 1995-10-18 |
| DERMATRON SKIN RESISTANCE METER (K883112) | Raymar Electronics | 1989-08-10 |
| EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER (K874850) | Epi-Scan Corp. | 1988-05-20 |
| UNIVERSAL EXAMINATION TABLE (K842108) | Engineering Dynamics Corp. | 1984-07-17 |
Track GZO automatically
Every clearance here is in the API, with alerts when new ones post.