510(k) K152040 ยท OMC Reduced- Montage Standard Electroencephalograph
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
| Applicant | Advanced Brain Monitoring, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Jul 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152040
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.