510(k) K980377 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
FONIX FP35 HEARING AID ANALYZER
| Applicant | Frye Electronics, Inc., Tigard OR, US |
| Decision | Substantially Equivalent, Mar 18, 1998 |
| Received | Feb 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980377
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.