510(k) K946232 ยท ESD Hearing Aid, Air-Conduction, Prescription
ACURA-EX
| Applicant | Lustgarten Multi-Tech Intl., Holliston MA, US |
| Decision | Substantially Equivalent, Jun 30, 1995 |
| Received | Dec 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946232
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.