510(k) K852098 ยท ESD Hearing Aid, Air-Conduction, Prescription
DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID
| Applicant | Miracle-Ear/Dahlberg, Inc., Golden Valley MN, US |
| Decision | Substantially Equivalent for Some Indications, Aug 16, 1985 |
| Received | May 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852098
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.