510(k) K915319 ยท ESD Hearing Aid, Air-Conduction, Prescription
RIONET HEARING AID HB-52AS
| Applicant | Rion Co. Ltd. Dba Rion Acoustic Device, Bristol PA, US |
| Decision | Substantially Equivalent, Jan 9, 1992 |
| Received | Nov 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915319
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.