510(k) K971807 ยท ESD Hearing Aid, Air-Conduction, Prescription
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
| Applicant | Hear-Right, Inc., Oklahoma City OK, US |
| Decision | Substantially Equivalent, Aug 7, 1997 |
| Received | May 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971807
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.