510(k) K893433 ยท ESD Hearing Aid, Air-Conduction, Prescription
PERSONAL AMPLIFIER MODEL ULTRA HELIX
| Applicant | Electone, Inc., Winter Park FL, US |
| Decision | Substantially Equivalent, Jun 14, 1989 |
| Received | May 2, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893433
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.