510(k) K221471 ยท GWE Stimulator, Photic, Evoked Response
E3 and Profile
| Applicant | Diagnosys, LLC, Lowell MA, US |
| Decision | Substantially Equivalent, Nov 22, 2022 |
| Received | May 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221471
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.