510(k) K970324 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
GSI SA60 DPOAE SYSTEM
| Applicant | Grason-Stadler, Inc., Milford NH, US |
| Decision | Substantially Equivalent, Jun 6, 1997 |
| Received | Jan 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970324
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.