510(k) K972373 ยท ESD Hearing Aid, Air-Conduction, Prescription
OVATION HDP
| Applicant | Orsonique, Inc., Laval, Quebec, CA |
| Decision | Substantially Equivalent, Jul 29, 1997 |
| Received | Jun 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972373
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.