510(k) K914816 ยท ESE Larynx, Artificial (Battery-Powered)
AMERICAN ARTIFICIAL LARYNX
| Applicant | Ultravoice, Ltd., Paoli PA, US |
| Decision | Substantially Equivalent, Feb 12, 1993 |
| Received | Oct 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914816
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.