510(k) K090277 ยท OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
NATUS SLEEPWORKS, MODEL 104017
| Applicant | Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Feb 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2021 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software Terminated |
OMB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.