510(k) K043491
- Device
- ENFANTTM
- Applicant
- DIOPSYS INC.
- 510(k) number
- K043491
- Product code
- GWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-16
- Date received
- 2004-12-17
- Regulation
- 882.1890
- Classification name
- Stimulator, Photic, Evoked Response
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH FONTANETTA
- Address
- 16 Chapin Rd. Suite 911 P.O. Box 672 Pine Brook NJ US 07058 07058
FDA Registration Numbers#
- 9612330
- 9613619
- 2080783
- 3013501110
- 3010611950
- 1650946
- 3012182497
- 1221363
- 3015491430
- 3007611554
- 3005581270
- 3007962724
- 8030229
- 3005955744
- 1119189
- 2243374
- 3004174467
- 9611252
- 3016852448
- 3006418479
- 3018094310
- 2521877
- 1052723
- 3010120146
- 2184161
- 3038189172
- 3001687738
- 9710486
- 3008773490
- 3008058195
- 3020018
- 1045254
- 3003851073
- 3004753785
- 3004883754
- 3006177498
- 2023374
Source Documents#
Other 510(k) Records For Product Code GWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221471 | E3 and Profile | Diagnosys, LLC | 2022-11-22 |
| K212936 | Vision Monitor- MonCvONE | Metrovision | 2022-11-21 |
| K211974 | LED PHOTIC System | Micromed S.P.A. | 2021-09-23 |
| K211643 | Vision Monitor - MonpackONE | Metrovision | 2021-07-26 |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020-04-23 |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 |
| K142567 | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | 2015-05-19 |
| K113785 | ADHERENT VISUAL STIMULATOR GOGGLES | Anschel Technology, Inc. | 2012-06-06 |
| K120104 | VISIONSEARCH 1 | Visionsearch Pty, Ltd. | 2012-05-21 |
| K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | Diopsys, Inc. | 2011-05-09 |
| K101691 | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | 2010-08-10 |
| K081591 | NEUCODIA | Verisci Corporation | 2009-05-15 |
| K043367 | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Lace Electronica S.R.L. | 2005-11-17 |
| K023525 | RETISCAN, RETIPORT | Roland Consult | 2004-03-26 |
| K022304 | ACCUMAP AUTOMATIC PERIMETER | Objectivision Pty , Ltd. | 2003-11-14 |
Legacy Summary#
summary
FDA Review#
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