510(k) K860993 ยท ESE Larynx, Artificial (Battery-Powered)
P.O. VOX
| Applicant | Bloomfield Research and Development, Inc., Hilton Head SC, US |
| Decision | Substantially Equivalent, Apr 25, 1986 |
| Received | Mar 17, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860993
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.