510(k) K191700 ยท GZP Stimulator, Mechanical, Evoked Response
EyeStat
| Applicant | Blinktbi, Inc., Charleston SC, US |
| Decision | Substantially Equivalent, Dec 9, 2019 |
| Received | Jun 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191700
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.