The following data is part of a premarket notification filed by Neuro Kinetics, Inc with the FDA for I-portal Portable Assessment System - Nystagmograph (i-pas).
| Device ID | K171884 |
| 510k Number | K171884 |
| Device Name: | I-Portal Portable Assessment System - Nystagmograph (I-PAS) |
| Classification | Nystagmograph |
| Applicant | Neuro Kinetics, Inc 128 Gamma Dr Blawnox, PA 15238 |
| Contact | Brian Sullivan |
| Correspondent | Brian Sullivan Neuro Kinetics, Inc 128 Gamma Dr Blawnox, 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 | 2017-06-23 |
| Decision Date | 2017-11-22 |
| Summary: | summary |