510(k) K853606 ยท ESD Hearing Aid, Air-Conduction, Prescription
PERSONAL AMPLIFIER COMMUNICATOR PREMIUM
| Applicant | Electone, Inc., Winter Park FL, US |
| Decision | Substantially Equivalent, Sep 23, 1985 |
| Received | Aug 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853606
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.