510(k) K143395 ยท EWO Audiometer
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
| Applicant | Otodynamics, Ltd., Hatfield, Herts, GB |
| Decision | Substantially Equivalent, Feb 23, 2015 |
| Received | Nov 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143395
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.