The following data is part of a premarket notification filed by Neuro Kinetics with the FDA for I-portal 4d Video Oculography Eye Tracking System (vog), I-portal Video Nystagmography System (vng), I-portal Neuro Otol.
| Device ID | K083603 |
| 510k Number | K083603 |
| Device Name: | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL |
| Classification | Nystagmograph |
| Applicant | NEURO KINETICS 128 GAMMA DR. Pittsburgh, PA 15238 |
| Contact | Aura Kullmann |
| Correspondent | Aura Kullmann NEURO KINETICS 128 GAMMA DR. Pittsburgh, PA 15238 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-05 |
| Decision Date | 2009-08-06 |