510(k) K143440 ยท GWQ Full-Montage Standard Electroencephalograph
Natus Quantum
| Applicant | Natus Medical Incorporated, Oakville, CA |
| Decision | Substantially Equivalent, Apr 20, 2015 |
| Received | Dec 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2015 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.
The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive el Terminated |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.