510(k) K963631 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
| Applicant | Omega Results, Dallas TX, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Sep 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963631
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.