510(k) K123079 ยท OMA Amplitude-Integrated Electroencephalograph
OLYMPIC BRAINZ MONITOR
| Applicant | Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, May 8, 2013 |
| Received | Oct 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Brand Name: OBM00002 OBM DAB (Digital Acquisition Box)
Product Name: OBM00002 OBM DAB (Digital Acquisition Box)
Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box)
Software Version: N/A
P Open, Classified |
OMA | None listed |
| Apr 1, 2020 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph Terminated |
OMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.