Neuro Kinetics, Inc.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2730-2015 | Class II | Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system | July 21, 2015 |
| Z-1795-2015 | Class II | I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary moveme | April 30, 2015 |
| Z-0966-2014 | Class II | Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visuall | November 21, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculograph | July 24, 2018 |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) | November 22, 2017 |
| K143607 | I-Portal NOTC, VNG and VOG | July 8, 2015 |
| K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), | August 6, 2009 |