I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
FDA 510(k) clearance K083603 · decided 2009-08-06
Clearance details
- K-number
- K083603
- Device name
- I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
- Applicant
- Neuro Kinetics
- Decision
- Substantially Equivalent
- Date received
- 2008-12-05
- Decision date
- 2009-08-06
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- GWN
- Device class
- 2
- Regulation number
- 882.1460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chai recall (Z-2730-2015) | Neuro Kinetics, Inc. | 2015-09-03 |
| I-Portal NOTC and VNG; a device used to measure, record, or visually display the involunta recall (Z-1795-2015) | Neuro Kinetics, Inc. | 2015-06-12 |
| Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or recall (Z-0966-2014) | Neuro Kinetics, Inc. | 2014-02-10 |
| VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for recall (Z-2253-2009) | Neuro Kinetics | 2009-09-30 |