Product code GZO
- Device name
- Device, Galvanic Skin Response Measurement
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1540
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150804 | QBioScan | Medeia, Inc. | 2015-10-19 |
| K152216 | SudoC | Ld Technology, LLC | 2015-09-24 |
| K141872 | SUDOSCAN | Impeto Medical, Inc. | 2014-11-21 |
| K131568 | SUDO PATH | Ld Technology, LLC | 2013-06-28 |
| K111308 | ZYTO HAND CRADLE | Zyto Technologies, Inc. | 2011-08-30 |
| K102166 | ELECTRO INTERSTITIAL SCAN | Ld Technology, LLC | 2010-12-10 |
| K100233 | SUDOSCAN | Impeto Medical | 2010-06-14 |
| K053004 | MSAS-VANTAGE | Biomeridian, Int. | 2006-01-13 |
| K032935 | EPI-SCAN, MODEL P 100 | Edx Epi-Scan, Inc. | 2003-11-20 |
| K023355 | ASYRA | Galloway Technologies, LLC | 2003-06-24 |
| K020360 | ABR-2000 | Meridian Co., Ltd. | 2002-08-29 |
| K020567 | AKUPORT M1 | Vibrant Health | 2002-05-02 |
| K020564 | EAV KINDLING 2000S GSR DEVICE | Virbrant Health | 2002-04-30 |
| K020565 | EAV COMBI-2 | Vibrant Health | 2002-04-30 |
| K020568 | AKUPORT M-2 | Vibrant Health | 2002-04-30 |
| K010897 | MERIDIAN-PORTABLE | Meridian Co., Ltd. | 2001-06-19 |
| K003480 | BIOFIND | Bio-Scan, Inc. | 2001-05-11 |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Meridian Co., Ltd. | 2000-11-03 |
| K993824 | MSAS PROFESSIONAL | Biomeridian, Int. | 2000-01-20 |
| K993202 | EIM-107 PREP-CHECK | General Devices | 1999-12-17 |
| K992129 | PHAZX VLD-100 | Phazx Systems, Inc. | 1999-09-17 |
| K970436 | E-READER | Natural Herbal Products, Inc. | 1997-08-15 |
| K943101 | GALVANIC SKIN RESPONSE DEVICE | Global Ent. | 1995-10-18 |
| K883112 | DERMATRON SKIN RESISTANCE METER | Raymar Electronics | 1989-08-10 |
| K874850 | EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER | Epi-Scan Corp. | 1988-05-20 |
| K842108 | UNIVERSAL EXAMINATION TABLE | Engineering Dynamics Corp. | 1984-07-17 |
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| 00850068747108 | Happy Health | HAPPY HEALTH, INC. | 2025-04-02 |
| 00850068747092 | Happy Health | HAPPY HEALTH, INC. | 2025-04-02 |
| 00840067103630 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-11-15 |
| 00840067103623 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-11-15 |
| 00840067103562 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-11-15 |
| 00840067103999 | Cadwell | CADWELL INDUSTRIES, INC. | 2024-08-23 |
| 00840067102992 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-08-23 |
| 00840067103524 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-06-21 |
| 00840067103517 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-06-21 |
| B322G0011 | ANS1 Software | LD TECHNOLOGY, LLC | 2024-03-05 |
| 00840067102893 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-03-04 |
| 00840067103609 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-03-04 |
| 00840067102916 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-03-04 |
| 00840067102909 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-03-04 |
| 00840067102879 | Cadwell Guardian | CADWELL INDUSTRIES, INC. | 2024-03-04 |
| 00840067103616 | Cascade IOMAX | CADWELL INDUSTRIES, INC. | 2021-10-15 |
| 00840067102862 | Cascade IOMAX | CADWELL INDUSTRIES, INC. | 2020-12-10 |
| 00840067102763 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2019-07-31 |
| 00840067102718 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2019-07-09 |
| 00840067102688 | IOMAX Adapter | CADWELL INDUSTRIES, INC. | 2019-05-13 |
| 00840067102671 | IOMAX Extender Pod | CADWELL INDUSTRIES, INC. | 2019-05-13 |
| 00840067102664 | IOMAX Adapter | CADWELL INDUSTRIES, INC. | 2019-05-13 |
| 00840067102657 | IOMAX Extender Pod | CADWELL INDUSTRIES, INC. | 2019-05-13 |
| 00840067102220 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2017-12-15 |
| 00840067102244 | Disposable Goggle Foam | CADWELL INDUSTRIES, INC. | 2017-07-11 |
| 00840067102053 | Cascade IOMAX | CADWELL INDUSTRIES, INC. | 2017-07-11 |
| 00840067100653 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2017-05-31 |
| 00840067100646 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2017-05-31 |
| 00840067100639 | Cascade IOMAX Intraoperative Monitor | CADWELL INDUSTRIES, INC. | 2017-05-31 |