510(k) K935400 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
FONIX 3500 HEARING AID ANALYZER
| Applicant | Frye Electronics, Inc., Tigard OR, US |
| Decision | Substantially Equivalent, Jan 14, 1994 |
| Received | Nov 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935400
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.