510(k) K943460 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
PORTAREM 2000
| Applicant | Starkey Laboratories, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Oct 21, 1994 |
| Received | Jul 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943460
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.