DIOPSYS NOVA VEP VISION TESTING SYSTEM
DIOPSYS INC.
DIOPSYS INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004174467 | 3004174467 | DIOPSYS INC. | 1 | N | 2026-01-01 | 1000 Kreider Drive STE 700 Middletown PA US 17057 |
| 3004174467 | 3004174467 | DIOPSYS INC. | 1 | N | 2020-04-25 | 16 CHAPIN ROAD SUITE 912 PINE BROOK NJ US 07058 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 23641 | 1365623913 | K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | GWE | 2011-05-09 |
| 342611 | 1902780782 | K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | GWE | 2011-05-09 |
| 23641 | 1044692674 | K043491 | ENFANTTM | GWE | 2005-03-16 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GWE | 3 | 2011-05-09 |
PMN#
ENFANTTM
DIOPSYS INC.
GUDID#
Diopsys® - Ganzfeld Dome
2017-05-05
Diopsys® - NOVA Software
2017-03-27
Diopsys® - NOVA ARGOS Vision Testing System
2017-03-27
Diopsys® - NOVA Vision Testing System
2017-03-27
Diopsys® - ERG Lid Electrodes, Box
2017-03-27
Diopsys® - ERG Lid Electrodes, Pouch
2017-03-27
Diopsys® - Disposable Hypoallergenic EEG Electrodes, Pouch/100
2017-03-27
Diopsys® - Braided EEG Snap Lead Wire Set, Bag
2017-03-27
Diopsys® - Single Channel EEG Filter/Amplifier Module
2017-03-27
Diopsys® - Braided ERG Lead Wire Set, Bag
2017-03-27
Diopsys® - Disposable Hypoallergenic EEG Electrodes, Case/600
2017-03-27
Diopsys® - ERG Lid Electrodes, Case
2017-03-27
Diopsys® - Disposable Hypoallergenic EEG Electrodes, Case/300
2017-03-27