510(k) K911063 ยท ESD Hearing Aid, Air-Conduction, Prescription
DAHLBERG MODEL LU BTE HEARING AID
| Applicant | Miracle-Ear, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 21, 1991 |
| Received | Mar 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911063
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.