GZO — Device, Galvanic Skin Response Measurement Class II
FDA product code GZO covers "Device, Galvanic Skin Response Measurement", a Class II medical device regulated under 21 CFR 882.1540. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GZO
- Device Class
- Class II
- Regulation Number
- 882.1540
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150804 | medeia | QBioScan | October 19, 2015 |
| K152216 | ld technology | SudoC | September 24, 2015 |
| K141872 | impeto medical | SUDOSCAN | November 21, 2014 |
| K131568 | ld technology | SUDO PATH | June 28, 2013 |
| K111308 | zyto technologies | ZYTO HAND CRADLE | August 30, 2011 |
| K102166 | ld technology | ELECTRO INTERSTITIAL SCAN | December 10, 2010 |
| K100233 | impeto medical | SUDOSCAN | June 14, 2010 |
| K053004 | biomeridian, int | MSAS-VANTAGE | January 13, 2006 |
| K032935 | edx epi-scan | EPI-SCAN, MODEL P 100 | November 20, 2003 |
| K023355 | galloway technologies | ASYRA | June 24, 2003 |
| K020360 | meridian co | ABR-2000 | August 29, 2002 |
| K020567 | vibrant health | AKUPORT M1 | May 2, 2002 |
| K020565 | vibrant health | EAV COMBI-2 | April 30, 2002 |
| K020568 | vibrant health | AKUPORT M-2 | April 30, 2002 |
| K020564 | virbrant health | EAV KINDLING 2000S GSR DEVICE | April 30, 2002 |
| K010897 | meridian co | MERIDIAN-PORTABLE | June 19, 2001 |
| K003480 | bio-scan | BIOFIND | May 11, 2001 |
| K001347 | meridian co | MERIDIAN-II AND MERDIAN-PLUS | November 3, 2000 |
| K993824 | biomeridian, int | MSAS PROFESSIONAL | January 20, 2000 |
| K993202 | general devices | EIM-107 PREP-CHECK | December 17, 1999 |