510(k) K800011 ยท ESD Hearing Aid, Air-Conduction, Prescription
RIONET HEARING AID HE-71
| Applicant | Rion Acoustic Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 29, 1980 |
| Received | Jan 4, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800011
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.