510(k) K801958 ยท ESD Hearing Aid, Air-Conduction, Prescription
RIONET HEARING AID HB-70H
| Applicant | Rion Acoustic Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 9, 1980 |
| Received | Jul 23, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801958
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.