510(k) K934483 ยท ESE Larynx, Artificial (Battery-Powered)
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
| Applicant | Mountain Precision Mfg. Ltd. Co., Boise ID, US |
| Decision | Substantially Equivalent, Mar 16, 1994 |
| Received | Sep 14, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934483
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.