510(k) K901503 ยท ESE Larynx, Artificial (Battery-Powered)
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
| Applicant | Stanton Magnetics, Inc., Plainview NY, US |
| Decision | Substantially Equivalent, Jun 28, 1990 |
| Received | Mar 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901503
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.