510(k) K970519 ยท ESD Hearing Aid, Air-Conduction, Prescription
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
| Applicant | Unitron Industries, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Apr 24, 1997 |
| Received | Feb 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970519
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.