510(k) K123701 ยท GWJ Stimulator, Auditory, Evoked Response
HEARLAB ACA
| Applicant | Frye Electronics, Inc., Tigard OR, US |
| Decision | Substantially Equivalent, Apr 5, 2013 |
| Received | Dec 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123701
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.