510(k) K971158 ยท ESD Hearing Aid, Air-Conduction, Prescription
DUALINE 400 CIC
| Applicant | Bernafon-Maico, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Mar 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971158
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.