510(k) K011135 ยท EWO Audiometer
GSI AUDERA
| Applicant | Nicolet Biomedical, Golden CO, US |
| Decision | Substantially Equivalent, Jul 26, 2001 |
| Received | Apr 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2008 | Cardinal Health, Inc GSI Audera (version 2.6 software) Viasys Healthcare, Inc.
Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725.
The GSI Audera is used as part of an audiometric t Terminated |
EWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.