510(k) K813583 ยท ESD Hearing Aid, Air-Conduction, Prescription
PHONIC EAR MODEL PE805CD
| Applicant | Phonic Ear, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 12, 1982 |
| Received | Dec 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813583
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.