510(k) K854311 ยท ESD Hearing Aid, Air-Conduction, Prescription
EARLENS
| Applicant | Sound Acoustic Systems, Ltd., Laguna CA, US |
| Decision | Substantially Equivalent, Apr 14, 1986 |
| Received | Oct 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854311
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.