510(k) K083603 ยท GWN Nystagmograph
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
| Applicant | Neuro Kinetics, Pittsburgh PA, US |
| Decision | Substantially Equivalent, Aug 6, 2009 |
| Received | Dec 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Neuro Kinetics, Inc. Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does Terminated |
GWN | None listed |
| Jun 12, 2015 | Neuro Kinetics, Inc. I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians i Terminated |
GWN | None listed |
| Feb 10, 2014 | Neuro Kinetics, Inc. Normative Data Template CD for use with the I-Portal devices.
Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. Terminated |
GWN | None listed |
| Sep 30, 2009 | Neuro Kinetics VEST 6.6 or earlier software for use with Neuro Kinetics products.
The device is used for vestibular testing. Terminated |
LXV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.