510(k) K130007 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
SLEEP PROFILER
| Applicant | Advanced Brain Monitoring, Inc., Dousman WI, US |
| Decision | Substantially Equivalent, Apr 17, 2013 |
| Received | Jan 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130007
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.