GWE — Stimulator, Photic, Evoked Response Class II
FDA product code GWE covers "Stimulator, Photic, Evoked Response", a Class II medical device regulated under 21 CFR 882.1890. 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
- GWE
- Device Class
- Class II
- Regulation Number
- 882.1890
- Submission Type
- 510(k)
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221471 | Diagnosys | E3 and Profile | Nov 22, 2022 |
| K212936 | Metrovision | Vision Monitor- MonCvONE | Nov 21, 2022 |
| K211974 | Micromed | LED PHOTIC System | Sep 23, 2021 |
| K211643 | Metrovision | Vision Monitor - MonpackONE | Jul 26, 2021 |
| K200705 | Cryptych Pty | Nurochek System | Apr 23, 2020 |
| K173936 | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Natus Photic Stimulator | Jun 15, 2018 |
| K142567 | Lkc Technologies | RETeval Visual Electrodiagnostic Device | May 19, 2015 |
| K113785 | Anschel Technology | ADHERENT VISUAL STIMULATOR GOGGLES | Jun 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 | Aug 10, 2010 |
| K081591 | Verisci Corporation | NEUCODIA | May 15, 2009 |
| K043367 | Lace Electronica | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Nov 17, 2005 |
| K043491 | Diopsys | ENFANTTM | Mar 16, 2005 |
| K023525 | Roland Consult | RETISCAN, RETIPORT | Mar 26, 2004 |
| K022304 | Objectivision Pty | ACCUMAP AUTOMATIC PERIMETER | Nov 14, 2003 |
| K011794 | Excel Tech. | XLTEK LED GOGGLES, MODEL LED-01 | Oct 1, 2001 |
| K001467 | Airsep | DA VINCHI EMG/EP ISA1004EP | Aug 1, 2000 |
| K991903 | Excel Tech. | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Aug 4, 1999 |
| K971214 | Cadwell Laboratories | KILOWIN | Jun 11, 1998 |