GWE — Stimulator, Photic, Evoked Response Class II
FDA Device Classification
Classification Details
- Product Code
- GWE
- Device Class
- Class II
- Regulation Number
- 882.1890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K221471 | diagnosys | E3 and Profile | November 22, 2022 |
| K212936 | metrovision | Vision Monitor- MonCvONE | November 21, 2022 |
| K211974 | micromed | LED PHOTIC System | September 23, 2021 |
| K211643 | metrovision | Vision Monitor - MonpackONE | July 26, 2021 |
| K200705 | cryptych pty | Nurochek System | April 23, 2020 |
| K173936 | natus medical incorporated dba excel-tech ltd. (xltek) | Natus Photic Stimulator | June 15, 2018 |
| K142567 | lkc technologies | RETeval Visual Electrodiagnostic Device | May 19, 2015 |
| K113785 | anschel technology | ADHERENT VISUAL STIMULATOR GOGGLES | June 6, 2012 |
| K120104 | visionsearch pty | VISIONSEARCH 1 | May 21, 2012 |
| K101763 | diopsys | DIOPSYS NOVA VEP VISION TESTING SYSTEM | May 9, 2011 |
| K101691 | lifelines | LIFELINES PHOTIC STIMULATOR | August 10, 2010 |
| K081591 | verisci corporation | NEUCODIA | May 15, 2009 |
| K043367 | lace electronica | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | November 17, 2005 |
| K043491 | diopsys | ENFANTTM | March 16, 2005 |
| K023525 | roland consult | RETISCAN, RETIPORT | March 26, 2004 |
| K022304 | objectivision pty | ACCUMAP AUTOMATIC PERIMETER | November 14, 2003 |
| K011794 | excel tech. | XLTEK LED GOGGLES, MODEL LED-01 | October 1, 2001 |
| K001467 | airsep | DA VINCHI EMG/EP ISA1004EP | August 1, 2000 |
| K991903 | excel tech. | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | August 4, 1999 |
| K971214 | cadwell laboratories | KILOWIN | June 11, 1998 |