510(k) K192186 ยท GWN Nystagmograph
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
| Applicant | Neurolign USA, LLC, Pittsburgh PA, US |
| Decision | Substantially Equivalent, Nov 29, 2019 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192186
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.