510(k) K780150 ยท EWO Audiometer
NEONATAL SCREENING AUDIOMETER
| Applicant | Telediagnostic Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 13, 1978 |
| Received | Jan 30, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780150
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.