510(k) K854158 ยท ESE Larynx, Artificial (Battery-Powered)
RESNICK EMITTER, ARTIFICIAL LARYNX
| Applicant | Dynamed Audio, Inc., Natrona Heights PA, US |
| Decision | Substantially Equivalent, Dec 13, 1985 |
| Received | Oct 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854158
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.