510(k) K180290 ยท GWQ Full-Montage Standard Electroencephalograph
Natus Brain Monitor Amplifier
| Applicant | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Feb 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph Open, Classified |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.