510(k) K081136 ยท ESD Hearing Aid, Air-Conduction, Prescription
LYRIC HEARING AID
| Applicant | Insound Medical, Inc., Newark CA, US |
| Decision | Substantially Equivalent, May 8, 2008 |
| Received | Apr 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081136
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2010 | InSound Medical, Inc. InSound Medical, Inc, Lyric in-canal hearing aid. Terminated |
ESD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.