510(k) K884046 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
| Applicant | Etymonic Design, Inc., Dorchester, Ontario, CA |
| Decision | Substantially Equivalent, Feb 13, 1989 |
| Received | Sep 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884046
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.