510(k) K854315 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARTECH MODEL IN TECH
| Applicant | Hearing Tech, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jan 21, 1986 |
| Received | Oct 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854315
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.