510(k) K971845 ยท ESD Hearing Aid, Air-Conduction, Prescription
HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
| Applicant | Sound Hearing Instruments, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 15, 1997 |
| Received | May 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971845
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.