510(k) K971399 ยท ESD Hearing Aid, Air-Conduction, Prescription
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
| Applicant | General Hearing Instruments, Inc., Harahan LA, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Apr 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971399
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.