The following data is part of a premarket notification filed by Neuro Kinetics, Inc. with the FDA for I-portal Neuro Otologic Test Center; I-portal Video Nystagmography System; I-portal Video Oculography Eye Tracking System.
| Device ID | K181025 |
| 510k Number | K181025 |
| Device Name: | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System |
| Classification | Nystagmograph |
| Applicant | Neuro Kinetics, Inc. 128 Gamma Drive Pittsburgh, PA 15238 |
| Contact | Robin C. Ashmore |
| Correspondent | Robin C. Ashmore Neuro Kinetics, Inc. 128 Gamma Drive Pittsburgh, PA 15238 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-07-24 |
| Summary: | summary |