510(k) K153412 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Sleep Profiler
| Applicant | Advanced Brain Monitoring, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 14, 2016 |
| Received | Nov 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153412
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.