510(k) K012415 ยท GWJ Stimulator, Auditory, Evoked Response
AURIS AEP
| Applicant | Synapsys, Inc., Jamaica NY, US |
| Decision | Substantially Equivalent, Dec 18, 2001 |
| Received | Jul 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012415
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.