510(k) K143607 ยท GWN Nystagmograph
I-Portal NOTC, VNG and VOG
| Applicant | Neuro Kinetics, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Jul 8, 2015 |
| Received | Dec 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143607
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.