510(k) K884371 ยท ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
| Applicant | Madsen Electronics (Canada) , Ltd., Oakville, Ontario, CA |
| Decision | Substantially Equivalent, Feb 13, 1989 |
| Received | Oct 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884371
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.