Excel-Tech Ltd. (Xltek)
CanadaFDA 510(k) applicant, unverified
- Devices
- 5
What Excel-Tech Ltd. (Xltek) makes
Excel-Tech Ltd. manufactures neurostimulation and monitoring devices, including the STELLATE GridView for deep brain stimulation lead positioning, the NEUROLINK IP (Model PK1113) for intracranial pressure monitoring, and the TREZ_HD for high-density electroencephalography (EEG) recording. The company also produces the NATUS SLEEPWORKS (Model 104017) system for polysomnography and the ICTA for intraoperative cortical mapping.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Stellate Gridview Ref K100126
510(k) 510(k)Neurolink Ip, Model PK1113 Ref K081741
510(k) 510(k)Trez_hd Ref K131266
510(k) 510(k)Natus Sleepworks, Model 104017 Ref K090277
510(k) 510(k)Icta Ref K120260
510(k) 510(k)
Frequently asked questions
How many devices does Excel-Tech Ltd. (Xltek) have in the registry?
The registry currently lists 5 devices for Excel-Tech Ltd. (Xltek). Devices recorded under merged duplicate company entries are counted once.
Which registries list Excel-Tech Ltd. (Xltek)'s devices?
Among its 5 most recently registered devices, Excel-Tech Ltd. (Xltek) has devices listed in FDA 510(k) (5 devices).
What risk classes do Excel-Tech Ltd. (Xltek)'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Excel-Tech Ltd. (Xltek)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Excel-Tech Ltd. (Xltek) in the registry?
The most recently registered devices listed for Excel-Tech Ltd. (Xltek) include STELLATE GRIDVIEW, NEUROLINK IP, MODEL PK1113, TREZ_HD and NATUS SLEEPWORKS, MODEL 104017.