FDA 510(k) Applications for Medical Device Product Code "GWE"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K001467 | AIRSEP CORP. | DA VINCHI EMG/EP ISA1004EP | 08/01/2000 |
K113785 | ANSCHEL TECHNOLOGY, INC. | ADHERENT VISUAL STIMULATOR GOGGLES | 06/06/2012 |
K971214 | CADWELL LABORATORIES, INC. | KILOWIN | 06/11/1998 |
K200705 | Cryptych Pty Ltd | Nurochek System | 04/23/2020 |
K221471 | Diagnosys LLC | E3 and Profile | 11/22/2022 |
K101763 | DIOPSYS INC. | DIOPSYS NOVA VEP VISION TESTING SYSTEM | 05/09/2011 |
K043491 | DIOPSYS INC. | ENFANTTM | 03/16/2005 |
K991903 | EXCEL TECH. LTD. | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | 08/04/1999 |
K011794 | EXCEL TECH. LTD. | XLTEK LED GOGGLES, MODEL LED-01 | 10/01/2001 |
K043367 | LACE ELECTRONICA S.R.L. | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | 11/17/2005 |
K101691 | LIFELINES LTD. | LIFELINES PHOTIC STIMULATOR | 08/10/2010 |
K142567 | LKC Technologies, Inc | RETeval Visual Electrodiagnostic Device | 05/19/2015 |
K211643 | Metrovision | Vision Monitor - MonpackONE | 07/26/2021 |
K212936 | Metrovision | Vision Monitor- MonCvONE | 11/21/2022 |
K211974 | Micromed S.p.A. | LED PHOTIC System | 09/23/2021 |
K173936 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) | Natus Photic Stimulator | 06/15/2018 |
K022304 | OBJECTIVISION PTY LTD. | ACCUMAP AUTOMATIC PERIMETER | 11/14/2003 |
K023525 | ROLAND CONSULT | RETISCAN, RETIPORT | 03/26/2004 |
K081591 | VERISCI CORPORATION | NEUCODIA | 05/15/2009 |
K120104 | VISIONSEARCH PTY LTD | VISIONSEARCH 1 | 05/21/2012 |