510(k) K003644 ยท GWN Nystagmograph
EYETECT TREMOR MONITOR UNIT (TMU)
| Applicant | Eyetect, LLC, Belleville, IL, US |
| Decision | Substantially Equivalent, Feb 1, 2001 |
| Received | Nov 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003644
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.