510(k) K891011 ยท ESD Hearing Aid, Air-Conduction, Prescription
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
| Applicant | Resound Corp., Redwood City CA, US |
| Decision | Substantially Equivalent, Mar 29, 1989 |
| Received | Feb 28, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891011
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.